Colorrectal Cancer
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Jun 01 – Jun 08, 2026
A randomised study of encorafenib, cetuximab, and FOLFIRI versus FOLFIRI with or without bevacizumab in BRAF V600E-mutant colorectal cancer: BREAKWATER Cohort 3.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The randomized phase of the BREAKWATER trial (Cohort 3) evaluated first-line encorafenib plus cetuximab with FOLFIRI versus FOLFIRI ± bevacizumab in 147 patients with previously untreated BRAF V600E-mutant metastatic colorectal cancer. Patients were assigned 1:1, and outcomes were assessed by blinded independent central review; primary endpoint was objective response rate (ORR), with progression-free survival (PFS), overall survival (OS), and safety as secondary endpoints. EC+FOLFIRI significantly improved ORR (64.4% vs 39.2%; OR 2.76, 95% CI 1.42-5.35; P = 0.0011) and PFS (median 15.2 vs 8.3 months; HR 0.44, 95% CI 0.27-0.70; P = 0.0002), and showed prolonged OS (HR 0.56, 95% CI 0.34-0.94; median not estimable vs 20.3 months). Serious adverse events occurred in 49.3% of EC+FOLFIRI and 44.1% of controls, with safety consistent with known profiles. Investigators conclude EC+FOLFIRI provides a new standard of care for this population.
10.1016/j.annonc.2026.04.017
Chemotherapy for patients with circulating tumour DNA positive, stage II colon cancer (CIRCULATE) - an AIO / ABCSG trial.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This prospective multi-center trial aimed to evaluate the role of adjuvant chemotherapy for ctDNA-positive stage II colon cancer using an academic tumor-informed NGS-based test. Patients with ctDNA positivity were randomized 2:1 to receive chemotherapy (capecitabine ± oxaliplatin) or observation, while ctDNA-negative patients were also randomized to observation or off-study. Despite early study termination, the per-protocol results revealed improved time-to-recurrence and disease-free survival with chemotherapy in ctDNA-positive patients (3-year recurrence: 19% vs 62%, HR 0.23, P=0.009). Although the primary ITT endpoint was not met, these data support using ctDNA testing to guide adjuvant therapy decisions in stage II colon cancer.
10.1016/j.annonc.2026.05.001
May 25 – Jun 01, 2026
Post-hoc analysis of adverse events during the EPOCH trial: reconsidering dosimetry.
EUR J NUCL MED MOL I · Q1 JOURNAL - RANK #10/212
This post-hoc analysis of the EPOCH trial examined the impact of yttrium-90 [Y]-radioembolization dosimetry on adverse events in colorectal cancer patients with liver metastases who had progressed following frontline chemotherapy. The study analyzed liver-related treatment-emergent adverse events (TEAEs) and bilirubin increases in 186 patients, reporting TEAEs in 50% of patients, grade 3 or higher TEAEs in 24%, and bilirubin increases in 14%. A theoretical model explored dosimetry parameters, finding that patients with lower fractional tumor involvement (<4.1%) were subjected to higher normal liver absorbed doses (up to 120 Gy). The analysis proposes revised dosimetry guidelines to mitigate TEAEs while maintaining therapeutic efficacy in radioembolization.
10.1007/s00259-026-07948-6
Apatinib enhances anti-PD-1 efficacy by inhibiting Exo70-mediated exosome secretion in pMMR/MSS colorectal cancer.
NPJ PRECIS ONCOL · Q1 JOURNAL - RANK #39/326
This single-arm, exploratory clinical study evaluated the efficacy of camrelizumab combined with apatinib in patients with advanced metastatic pMMR/MSS colorectal cancer who had received third-line or later treatment (NCT04067986). Results showed that apatinib significantly enhanced the therapeutic efficacy of immunotherapy, with mechanistic insights revealing reduced exosomal PD-L1 levels via inhibition of tumor-derived exosome secretion mediated by Exo70. The study provides a theoretical rationale for combining camrelizumab and apatinib in this patient population. No specific numerical efficacy results (e.g., response rates) were reported in the abstract.
10.1038/s41698-026-01518-7
Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin: a phase I study in patients with advanced and/or metastatic solid tumors.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin (CA) in 60 patients with advanced/metastatic CEA-positive solid tumors. The study comprised two parts: single-dose (0.1-6 mg, n=5) and multiple ascending doses (10-40 mg q2w, n=31; 6-30 mg qw, n=24), establishing an MTD of 30 mg q2w with dose-limiting toxicities including Gr4 hypophosphatemia and thrombocytopenia. Pharmacokinetics showed dose-proportional exposure (6-40 mg), and pharmacodynamics revealed preferential expansion of CD8+ T and NK cells. No objective responses were observed, but 11% (6/53) achieved stable disease (median duration 4.5 months), supporting further combination therapy development.
10.1016/j.esmoop.2026.107697
Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial.
LANCET GASTROENTEROL · Q1 JOURNAL - RANK #2/147TOP-TIER
This multicentre, open-label, randomised, controlled, phase 3 non-inferiority trial (TESAR) compared adjuvant chemoradiotherapy (25 x 1.8 Gy with capecitabine) to completion total mesorectal excision (cTME) in 202 patients with locally excised high-risk pT1 and low-risk T2 rectal cancer. The primary endpoint was 3-year locoregional recurrence (non-inferiority margin 7%). Estimated 3-year recurrence was 5.0% after chemoradiotherapy vs. 1.1% after cTME, with a non-significant difference (3.9%, 90% CI 0.0-9.4; p=0.16), failing to demonstrate non-inferiority. However, unsalvageable recurrence rates were low (1.3% vs. 0.0%), and 3-year stoma rates were significantly lower after chemoradiotherapy (2.6% vs. 45.4%; p<0.0001), with comparable overall survival. The authors conclude that adjuvant chemoradiotherapy challenges cTME as standard of care due to reduced morbidity and stoma rates, despite not meeting formal non-inferiority for locoregional recurrence.
10.1016/S2468-1253(26)00109-3
May 18 – May 25, 2026
A randomized controlled trial comparing robotic NOSES versus robotic TME for Mid-rectal cancer: short-term oncological and perioperative outcomes.
J ROBOT SURG · Q1 JOURNAL - RANK #48/312
The study aimed to compare perioperative and short-term oncological outcomes between robotic NOSES and robotic TME for mid-rectal cancer in a prospective randomized clinical trial involving 150 eligible participants, with 140 analyzed (71 R-TME and 69 R-NOSES). Methodologically, the trial employed 1:1 randomization and measured intraoperative and pathological metrics such as blood loss, operative duration, and lymph node harvest, as well as postoperative recovery indicators. While overall complication rates were similar (R-NOSES 13.0% vs. R-TME 15.5%, P=0.679), R-NOSES had statistically lower wound complications (0.0% vs. 5.6%, P=0.045), earlier flatus and diet resumption, and reduced VAS pain scores. The authors conclude R-NOSES is safe and offers superior recovery benefits compared to R-TME for selected mid-rectal cancer patients.
10.1007/s11701-026-03494-3
Does Radiation Boost Dose Affect Organ Preservation Rates? A Secondary Analysis of the Organ Preservation in Patients With Rectal Adenocarcinoma Trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
The prospective, randomized clinical trial in rectal adenocarcinoma tested whether increasing the total radiation boost dose during total neoadjuvant therapy could enhance organ preservation (OP). Patients with stage II/III rectal cancer were enrolled and randomized to different sequences of chemotherapy and chemoradiation, receiving either a standard boost dose (median total 5000 cGy) or a high boost dose (median total 5400 cGy). The unplanned secondary analysis showed no significant difference in clinical complete response or long-term OP rates, with 3-year OP of 52% in the standard-dose group versus 47% in the higher-dose group (P > .05). Investigators concluded that higher-dose boost did not increase the probability or durability of OP.
10.1016/j.ijrobp.2026.03.056
May 11 – May 18, 2026
Postoperative Hepatic Arterial Infusion With Oxaliplatin After Surgery of Four or More Colorectal Liver Metastases: A Randomized Phase II Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This randomized phase II trial compared postoperative hepatic arterial infusion (HAI) of oxaliplatin plus intravenous (IV) fluorouracil/leucovorin (LV5FU2) with standard IV oxaliplatin + LV5FU2 in 99 patients who had undergone curative resection or ablation of ≥4 colorectal liver metastases. Patients (ECOG 0-1) were allocated 1:1 to HAI (n = 50) or IV (n = 49) for ≥3 months; primary endpoint was hepatic recurrence-free survival (h-RFS) with follow-up of 59 months. Median h-RFS was 25 months with HAI versus 12 months with IV (HR 0.63, 95% CI 0.40-0.99; p = 0.047); median RFS was 14 vs 9 months (HR 0.63, p = 0.03) and median overall survival 74 vs 57 months (HR 0.61, p = 0.11), while grade 3-4 adverse events occurred in 58% vs 32%. The study concludes that adjuvant HAI oxaliplatin improves hepatic disease control with acceptable safety and merits phase III testing.
10.1200/JCO-25-01737
Neoadjuvant mFOLFOXIRI with or without cadonilimab versus mFOLFOX6 in locally advanced colorectal cancer: A randomized phase 2 trial (OPTICAL-2).
MED-CAMBRIDGE · Q1 JOURNAL - RANK #11/195TOP-TIER
This open-label, randomized phase II trial (OPTICAL-2) evaluated whether adding the bispecific PD-1/CTLA-4 antibody cadonilimab to intensive neoadjuvant chemotherapy enhances tumor eradication in proficient-MMR/microsatellite-stable locally advanced colorectal cancer. A total of 123 patients were randomized 1:1:1 to six cycles of mFOLFOXIRI + cadonilimab, mFOLFOXIRI, or standard mFOLFOX6 before surgery and adjuvant chemotherapy; the primary endpoint was pathological complete response (pCR). pCR rates were 26.8% with mFOLFOXIRI + cadonilimab versus 14.6% for mFOLFOXIRI and 9.8% for mFOLFOX6 (OR 3.4 vs mFOLFOX6, 95% CI 1.04–13.24; p = 0.046); major pathological response occurred in 68.3%, 46.3%, and 43.9% of patients, respectively (p = 0.026). Grade ≥3 adverse events, mainly liver enzyme elevations and neutropenia, were considered manageable, leading investigators to conclude that adding cadonilimab significantly improves neoadjuvant efficacy with acceptable safety, warranting further study.
10.1016/j.medj.2026.101141
Total Neoadjuvant Therapy with FOLFOX Followed by Short-Course Radiation in Locally Advanced Rectal Cancer-An Alternative Approach Evaluated in a Single-Center Clinical Trial.
J CLIN MED · Q1 JOURNAL - RANK #65/332
This single-center, phase II clinical trial evaluated the efficacy and safety of sequencing FOLFOX chemotherapy followed by short-course radiation therapy (SCRT) as total neoadjuvant therapy (TnT) in treatment-naïve adults with non-metastatic, locally advanced rectal adenocarcinoma. Twelve patients were enrolled; the primary endpoint was clinical or near-complete response (cCR/nCR) rate, with secondary endpoints including 1-year disease-free survival (DFS) and R0 resection rate. Four patients (33%, 95% CI: 9.9%-65.1%) achieved cCR/nCR and were managed non-operatively, all remaining disease-free at analysis, with a 1-year DFS of 100%; median overall survival (OS) was not reached. The study concludes that TnT with FOLFOX followed by SCRT is safe and effective, though the cCR/nCR rate was lower than established benchmarks for organ preservation.
10.3390/jcm15093192
Phase III randomized placebo-controlled trial on repurposing olanzapine for prevention of radiotherapy induced nausea and vomiting (RINV): CTRI/2022/01/039723.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This prospective, double-blind, phase III randomized placebo-controlled trial assessed the efficacy of olanzapine (5 mg daily) alongside standard ondansetron in preventing radiotherapy-induced nausea and vomiting (RINV) during abdominal-pelvic radiation therapy in 301 patients. The olanzapine group showed significantly higher rates of ‘no/minimal’ nausea (85.8% vs. 16.3%, p<0.001) and vomiting (95.9% vs. 74.5%, p<0.001) compared to placebo, along with reduced use of rescue therapy and fewer cases of severe nausea or vomiting (e.g., grade ≥2 nausea: 7.4% vs. 67%, p=0.001). Adverse reactions in the olanzapine group were mild (e.g., drowsiness and orthostatic hypotension), and no grade 4/5 toxicities were reported. The trial concluded that adding olanzapine to standard antiemetics significantly reduces RINV with manageable side effects, improving patient outcomes during abdominal-pelvic radiotherapy.
10.1016/j.radonc.2026.111571
Impact of continuous care based on multidisciplinary collaboration on the quality of life of patients with colorectal cancer undergoing chemotherapy.
FRONT MED-LAUSANNE · Q1 JOURNAL - RANK #61/332
This prospective randomized controlled trial investigated the impact of a multidisciplinary collaborative continuous care model compared to routine care on quality of life and other outcomes for 120 colorectal cancer patients receiving chemotherapy. Participants in the study group received individualized interventions, including nutritional and symptom management, health education, psychological counseling, peer support, and home visits, while the control group received routine care. After 3 months, the study group demonstrated significantly better outcomes across multiple validated measures, including gastrointestinal function (lower GSRS scores), fatigue (lower CFS scores), psychological resilience (higher CD-RISC scores), self-management efficacy (higher SUPPH scores), and quality of life (higher WHOQOL-BREF scores), as well as lower incidence of chemotherapy-related adverse reactions and improved medication adherence. The study concludes that this model provides effective short-term improvement in both physical and psychological outcomes, with further research needed to assess long-term effects and clinical outcomes.
10.3389/fmed.2026.1799635
The SHERPA trial: A phase I study combining SHP2 inhibitor RMC-4630 and ERK inhibitor LY3214996 in patients with KRAS-mutant pancreatic, non-small cell lung and colorectal cancer.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
SHP2 inhibitor RMC-4630 plus ERK inhibitor LY3214996 were tested in a phase I 3+3 dose-escalation trial of 24 patients with KRAS-mutant pancreatic, non-small cell lung, or colorectal cancer. The primary objective was determining the recommended phase 2 dose (RP2D), with patients receiving RMC-4630 weekly and LY3214996 daily in 28-day cycles. Dose-limiting toxicities at three of four dose levels included grade 3 thrombocytopenia, grade 2 decreased left ventricular ejection fraction, and grade 3 acute kidney injury and diarrhea. Insufficient drug exposure was reached due to toxicity, no radiological responses were observed, and the trial was discontinued without establishing an RP2D.
10.1016/j.ejca.2026.116782
Twenty-Three-Year Benefits of Sigmoidoscopy Screening for Colorectal Cancer : A Randomized Trial.
ANN INTERN MED · Q1 JOURNAL - RANK #9/332TOP-TIER
This multicenter, 23-year, prospective, randomized controlled trial from Norway aimed to evaluate the long-term effectiveness of once-only sigmoidoscopy, with or without a fecal immunochemical test, in reducing colorectal cancer (CRC) incidence and mortality. Investigators enrolled 100,210 participants aged 50 to 64 years and analyzed 98,654 in intention-to-treat, comparing 20,552 screening patients with 78,102 no screening controls. Results showed that men receiving screening had a 23-year CRC rate of 4.3% versus 6.0% for controls (risk difference: –1.7 percentage points; 95% CI, –2.2 to –1.2) and a CRC death risk of 1.4% versus 2.2% (risk difference: –0.8 percentage points; 95% CI, –1.1 to –0.5). Sigmoidoscopy screening reduced overall CRC incidence more in men than women and lowered CRC mortality only in men.
10.7326/ANNALS-25-05456
May 04 – May 11, 2026
Sequential versus upfront oxaliplatin-based therapy in metastatic colorectal cancer: long-term outcomes of a randomized phase 3 trial.
COMMUN MED-LONDON · Q1 JOURNAL - RANK #33/195
This phase 3 randomized, open-label, multicenter trial evaluated sequential versus upfront oxaliplatin-based therapy in 311 patients with previously untreated metastatic colorectal cancer in Japan. Patients were randomized to either fluoropyrimidine plus bevacizumab with oxaliplatin at progression or upfront fluoropyrimidine, oxaliplatin, and bevacizumab, and quality of life was prospectively assessed by patient-reported questionnaires. Median overall survival was 27.2 months for sequential therapy and 27.4 months for upfront therapy (hazard ratio 1.00, 95% CI 0.76-1.33, p=0.98), with no differences in time-restricted or milestone analyses; sequential therapy had a lower early treatment burden. Updated findings indicate comparable survival between strategies, with sequential treatment preferred for minimizing early adverse effects.
10.1038/s43856-026-01633-3
Favorable safety outcomes of a perioperative propranolol and etodolac regimen in cancer patients in four randomized controlled trials.
FRONT PHARMACOL · Q1 JOURNAL - RANK #51/352
This study describes four small prospective, randomized controlled trials of perioperative propranolol and etodolac in 148 breast, colorectal, and pancreatic cancer patients. The regimen started 5 days before surgery and continued up to 30 days postoperatively, with propranolol titrated from 20 mg b.i.d to 80 mg b.i.d on surgery day and similarly adjusted later, while 400 mg b.i.d of etodolac was maintained. The primary endpoints were perioperative safety outcomes (AEs up to 30 days and 16 blood indices), showing manageable side effects such as bradycardia (12% in treated) and some changes in blood markers that did not remain significant after FDR correction. The secondary outcome indicated an improvement in 8-year DFS for CRC patients (2/15 vs. 9/18, p=0.034), suggesting the potential long-term efficacy of this combination therapy.
10.3389/fphar.2026.1823113
Total neoadjuvant chemotherapy combined with PD‑1 blockade and IL‑2 in MSS/pMMR locally advanced rectal cancer: short-term results of a prospective, single-arm phase II study.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This single-arm, open-label, prospective phase II study enrolled 33 patients with microsatellite stable (MSS)/proficient mismatch repair (pMMR) locally advanced rectal cancer, administering neoadjuvant CapOX chemotherapy, PD-1 blockade (sintilimab), and IL-2 across six cycles, followed by radical surgery. The study achieved a 100% R0 resection rate; the pathological complete response rate was 42.4% and partial response rate 57.6%. No grade IV/V adverse events or treatment-related deaths occurred, and follow-up (median 25.5 weeks) showed no recurrences. Analysis indicated significant immune activation in pCR patients; authors conclude the regimen is efficacious and warrants further validation.
10.1038/s41392-026-02683-8
Apr 27 – May 04, 2026
Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase I clinical trial (NCT05029882) evaluated the antibody-drug conjugate Temab-A in patients with advanced solid tumors, including a metastatic colorectal cancer (mCRC) dose expansion arm. The study enrolled 122 mCRC patients across dose escalation and randomized expansion, with Temab-A administered intravenously every 3 weeks at doses from 1.6 to 3.0 mg/kg. Key efficacy results across all mCRC doses included a 15.6% overall response rate, 74.6% disease control rate, median progression-free survival of 4.6 months, and median overall survival of 10.4 months. The authors concluded that 2.4 mg/kg every 3 weeks provides a tolerable safety profile with promising antitumor activity.
10.1200/JCO-25-01525
Effect of one or two cycles of dual immunotherapy with nivolumab and ipilimumab in patients with mismatch repair-deficient rectal cancer (RESET-R): interim results from a multicentre, single-arm, phase 2 trial.
LANCET GASTROENTEROL · Q1 JOURNAL - RANK #2/147TOP-TIER
The RESET-R trial evaluated the efficacy and safety of short-course preoperative dual immunotherapy (nivolumab and ipilimumab) in patients with early or locally advanced mismatch repair-deficient (dMMR) rectal cancer. This multicentre, single-arm, phase 2 study enrolled 16 patients (stage I-III) who received one or two cycles of treatment, with the endpoint being clinical complete response (cCR) at day 93. All 16 patients (100%) achieved cCR (11 after one cycle, 5 after two), with manageable toxicity (19% grade 3 adverse events) and no progression or recurrence during a median 16-month follow-up. The findings support the potential of this regimen for organ-preserving treatment, though longer follow-up is needed to confirm durability.
10.1016/S2468-1253(26)00047-6
Nivolumab Plus Ipilimumab in Patients With Solid Tumors With High Tumor Mutation Burden: Results From the Targeted Agent and Profiling Utilization Registry Study.
JCO PRECIS ONCOL · Q1 JOURNAL - RANK #57/326
This phase II basket trial (TAPUR) evaluated nivolumab plus ipilimumab in advanced cancer patients with high tumor mutation burden (≥10 mut/Mb). Three cohorts were enrolled: colorectal cancer (CRC, N=12), breast cancer (BC, N=13), and other solid tumors (HP, N=26). Disease control (DC) at ≥16 weeks was the primary endpoint; DC rates were 33% (BC) and 32% (HP), significantly exceeding the null rate of 15%, while the CRC cohort failed to meet the threshold. The authors conclude N+I demonstrated antitumor activity in BC and HP cohorts but not CRC.
10.1200/PO-25-01205
Phase II trial of encapsulated rapamycin to reduce polyp burden associated with familial adenomatous polyposis.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase II trial prospectively enrolled 30 FAP patients to three dosing regimens of encapsulated rapamycin (eRapa) to assess safety and efficacy in reducing polyp burden. The primary endpoints included safety/tolerability, pharmacokinetics, and percentage change from baseline (PCFB) in colorectal polyp burden at 6 months. Cohort 1 (every other day) showed the largest median decrease in colorectal polyp burden at 6 months (-39.4%, p=0.28), while intermittent dosing cohorts significantly reduced duodenal polyp burden at 6 months (p=0.04). The authors concluded eRapa was safe and tolerable, selecting the 0.5 mg daily every-other-week schedule for an upcoming phase III trial.
10.1158/1078-0432.CCR-25-4126
Apr 20 – Apr 27, 2026
Cetuximab plus capecitabine every three weeks as first-line maintenance therapy for RAS/BRAF wild-type metastatic colorectal cancer: a phase Ib dose-escalation study.
NPJ PRECIS ONCOL · Q1 JOURNAL - RANK #39/326
This phase Ib, nonrandomized 3+3 dose-escalation clinical trial evaluated the safety and pharmacokinetics of cetuximab (400-700 mg/m² every three weeks) plus capecitabine for first-line maintenance in RAS/BRAF wild-type metastatic colorectal cancer after induction. Twenty-four human patients participated, with 18 on the experimental every-three-week regimen and 6 on a standard every-two-week reference arm for pharmacokinetic comparison. No maximum tolerated dose was reached up to 700 mg/m² Q3W, safety profiles were consistent with prior knowledge, and cetuximab trough concentrations at 700 mg/m² Q3W approached those of the reference; exploratory median progression-free survival was 13.4 months. The study proposes cetuximab 700 mg/m² Q3W plus capecitabine as the recommended phase II dose for further evaluation.
10.1038/s41698-026-01429-7
Cibisatamab and FAP-4-1BBL in microsatellite-stable colorectal cancer: a phase 1b trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This phase 1b open-label clinical trial tested cibisatamab, a CEA-specific bispecific T cell engager, combined with FAP-4-1BBL, in 52 patients with microsatellite-stable metastatic colorectal cancer previously treated with two or more regimens. Patients received escalating doses of FAP-4-1BBL plus cibisatamab weekly or every three weeks, following obinutuzumab pretreatment; the primary endpoint was safety, with secondary endpoints including antitumor activity and biomarker analyses. Manageable safety was observed, with dose-limiting toxicities in 3.8% and confirmed partial responses in 13.5% (7/52 patients). The regimen demonstrated systemic immune activation and increased intratumoral CD8+ T cell infiltration, supporting feasibility and further development.
10.1038/s41591-026-04380-z
A preliminary exploratory clinical study of Xiao-Chai-Hu-Tang co-administered with irinotecan-based chemotherapy in advanced colorectal cancer.
J ETHNOPHARMACOL · Q1 JOURNAL - RANK #5/45
This preliminary clinical study prospectively evaluated the short-term safety of co-administering Xiao-Chai-Hu-Tang (XCHT) with an irinotecan-based chemotherapy regimen (FOLFIRI) in six postmenopausal women with advanced colorectal cancer. Patients received XCHT daily for five days, with irinotecan given intravenously on day four, and safety was assessed via clinical monitoring and blood tests, including pharmacokinetic profiling. During Cycle 1, grade 1 diarrhea occurred in 5/6 patients and grade 2 in 1/6 patient, with no grade 3-4 diarrhea; pharmacokinetic profiles of irinotecan and its metabolites were similar to historical controls. The study concludes that XCHT co-administration with FOLFIRI is preliminarily safe and recommends further randomized controlled trials.
10.1016/j.jep.2026.121723
Apr 13 – Apr 20, 2026
The effect of thunder-fire moxibustion on cancer-related fatigue in patients with Qi stagnation and blood stasis type colorectal cancer undergoing chemotherapy: a randomized controlled trial.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
The primary aim of this randomized controlled trial was to assess the effect of thunder-fire moxibustion (TFM) on cancer-related fatigue in patients with Qi stagnation and blood stasis syndrome undergoing chemotherapy for colorectal cancer. Seventy-seven patients were randomized to receive either conventional care alone or conventional care plus TFM, with interventions administered in two courses of five sessions each; outcomes included changes in Revised Piper Fatigue Scale scores as well as measures of sleep quality, quality of life, TCM syndrome scores, blood indicators, and inflammatory markers. The study found that thunder-fire moxibustion was effective in reducing fatigue and improving sleep quality and overall quality of life during chemotherapy, as indicated by improvements in relevant assessment tools. The authors concluded that TFM is a potentially beneficial supportive therapy for managing fatigue in this patient population.
10.1007/s00520-026-10673-3
Efficacy of Perioperative Pembrolizumab in Mismatch Repair Deficient/Microsatellite Unstable Localized Colorectal Cancers: Results of the Phase II Trial IMHOTEP.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The IMHOTEP trial was a prospective multicenter phase II study evaluating the efficacy and safety of perioperative pembrolizumab in patients with resectable dMMR/MSI colorectal cancer (CRC). Patients received one or two cycles of IV pembrolizumab 400 mg every 6 weeks before surgery, followed by a total treatment duration of one year, with primary endpoint being pathologic complete response (pCR) rate. Among 72 evaluable patients, 38 (52.7%, 95% CI: 41.4-63.9) achieved pCR, with rates increasing from 46% after one cycle to 68.2% after two cycles (p=0.0125), and only three disease recurrences occurred over a median follow-up of 24.5 months. The study concluded that perioperative pembrolizumab is feasible and safe, demonstrating high pCR rates in localized dMMR/MSI CRC.
10.1200/JCO-25-02169
STRATEGIC-1: multiple-line, randomized, open-label GERCOR-PRODIGE-39 phase III trial in unresectable RAS/BRAF wild-type metastatic colorectal cancer.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This randomized, open-label phase III trial aimed to determine the optimal sequencing of chemotherapy plus targeted agents for untreated, unresectable RAS/BRAF wild-type metastatic colorectal cancer, comparing FOLFIRI-cetuximab followed by mFOLFOX6-bevacizumab (arm A) versus OPTIMOX-bevacizumab then FOLFIRI-bevacizumab followed by EGFR monoclonal antibody ± irinotecan (arm B). In 263 patients (131 vs 132), after a median follow-up of 68.4 months (95% CI, 76.5–98.0), the median duration of disease control was 22.8 months (95% CI, 20.4–28.8) in arm A versus 23.5 months (95% CI, 17.9–26.3) in arm B (HR=1.01, 95% CI, 0.76–1.34; P=0.945), and median overall survival was 40.4 months (95% CI, 32.4–51.1) versus 34.4 months (95% CI, 27.5–42.2) (HR=1.30, 95% CI, 0.99–1.72). First-line overall response rate favored arm A (82.4% vs 65.4%), while second-line ORR was similar (20.7% vs 16.4%), and adverse events matched known safety profiles. The study did not meet its primary endpoint and was inconclusive for identifying a superior treatment strategy in this population.
10.1038/s41392-026-02639-y
Apr 06 – Apr 13, 2026
Irinotecan with trifluridine/tipiracil and bevacizumab for second-line metastatic colorectal cancer: a phase II multicenter study.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This multicenter, single-arm phase II clinical trial enrolled 60 patients with metastatic colorectal cancer refractory to fluoropyrimidine- and oxaliplatin-based therapy to evaluate a second-line regimen of trifluridine/tipiracil (TAS-102) plus irinotecan and bevacizumab, administered bi-weekly. The primary endpoint, objective response rate, was 18.3 % (2 complete and 9 partial responses), with a disease control rate of 83.3 %. Median progression-free survival was 6.6 months (95 % CI 4.39–8.81) and median overall survival was 17.3 months (95 % CI 13.55–21.05); prior primary-tumor resection was associated with longer PFS (8.9 vs 5.2 months, p = 0.004) and OS (21.9 vs 16.2 months, p = 0.048). Treatment-related adverse events were common but manageable, with grade 3/4 neutropenia in 48.3 % and febrile neutropenia in 8.3 %, supporting further investigation of this regimen.
10.1038/s41392-026-02634-3
Safety and efficacy of lapatinib, binimetinib, and vinorelbine for RAS mutant metastatic colorectal cancer: results of the RASTRIC Phase I/II trial.
BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This prospective Phase I/II clinical trial evaluated the safety and efficacy of a triple therapy regimen (lapatinib, binimetinib, and vinorelbine) in forty patients with RAS-mutant metastatic colorectal cancer. The methodology included dose escalation, determination of the recommended Phase II regimen, pharmacokinetic analyses, and assessment of overall response rate using Simon’s two-stage design. Key results showed a Maximum Tolerated Dose of lapatinib 750 mg QD, binimetinib 30 mg BID (both 5 days on/2 days off), and vinorelbine 17.5 mg/m² on days 3 and 10 every 21 days, with toxicities primarily being diarrhea (75%), rash (65%), and increased CPK (57%); among 33 evaluable patients, 0 had objective responses and 9 (27%) achieved stable disease (maximum duration 297 days). The authors concluded that the regimen had moderate tolerability but insufficient efficacy, leading to early termination, and underscored the challenges in translating organoid-derived combination therapies to clinical practice.
10.1038/s41416-026-03398-x