Gastric and Esophageal Cancer
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Oct 12 – Oct 19, 2026
Nivolumab-Ipilimumab for Localized Microsatellite Instability-High Gastric/Gastroesophageal Junction Adenocarcinoma: The Phase 2 NEONIPIGA Nonrandomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
The NEONIPIGA phase 2 nonrandomized clinical trial evaluated neoadjuvant nivolumab plus ipilimumab followed by surgery and adjuvant nivolumab in 32 patients with localized deficient mismatch repair/microsatellite instability-high gastric or gastroesophageal junction adenocarcinoma. The primary end point of pathological complete response was previously reported; this analysis reports long-term secondary outcomes with a median follow-up of 48.3 months. Among 32 patients in the intention-to-treat population, 4-year overall survival was 84.1%, and in 31 patients eligible for surgery, 4-year event-free survival was 83.5%; 17 of 29 patients (59%) achieved pathological complete response. The immunotherapy regimen was associated with sustained long-term survival, but no clear evidence of improved survival over surgery alone was observed.
10.1001/jamaoncol.2026.4162
Feasibility of a tubeless enhanced recovery strategy in non-high-risk patients undergoing laparoscopy-assisted gastrectomy for gastric cancer.
SURG ENDOSC · Q1 JOURNAL - RANK #64/312
This prospective non-randomized controlled trial evaluated the feasibility of a tubeless enhanced recovery after surgery (ERAS) protocol in 205 non-high-risk gastric cancer patients undergoing laparoscopy-assisted gastrectomy. Patients were allocated 1:1 to ERAS-tubeless or ERAS-tube groups using a team-level allocation protocol, with postoperative hospital stay as the primary outcome. The tubeless group had significantly shorter mean hospital stays (6.0 vs. 7.3 days; P<0.001) and higher quality-of-life scores on multiple domains, without increased early complications. The authors conclude that the ERAS-tubeless strategy facilitates recovery and enhances patient experience, warranting further validation.
10.1007/s00464-026-13467-0
Oct 05 – Oct 12, 2026
Effect of a Computer-Aided Device on Endoscopists’ Biopsy Practice for Gastric Neoplasms: A Secondary Analysis of a Randomized Controlled Trial.
DIGEST ENDOSC · Q1 JOURNAL - RANK #17/312
This secondary analysis of a randomized controlled trial evaluated whether AI-assisted endoscopy improves endoscopists’ biopsy strategies for gastric neoplasms. The trial compared AI-assisted screening (n=13,440) versus standard screening (n=12,561), with the AI group stratified into red-box and non-red-box subgroups based on AI alerts. The red-box group showed significantly lower non-biopsy rates (18.00% vs 43.26% and 45.60%, p<0.001) and higher neoplasm biopsy efficiency (8.19% vs 0.36% and 1.77%, p<0.001), with red-box classification independently associated with lower non-biopsy rates (IRR 0.393, 95% CI 0.360-0.429). The authors conclude that red-box classification promotes more targeted biopsy sampling without causing indiscriminate biopsies from false-positive alerts.
10.1111/den.70302
First-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in unresectable advanced/metastatic esophageal squamous cell carcinoma: minimum 3-year survival follow-up of a randomized phase 3 trial (RATIONALE-306).
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This randomized phase 3 trial evaluated first-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in 649 patients with unresectable advanced/metastatic esophageal squamous cell carcinoma. At a minimum 3-year follow-up, tislelizumab plus chemotherapy significantly improved overall survival (17.2 vs 10.6 months; HR 0.70; 95% CI 0.59-0.80), with 15.0% versus 2.9% progression-free at 3 years. Safety was tolerable with no new signals, and quality of life favored tislelizumab, with median time to deterioration of physical functioning not reached versus 18.8 months. The authors conclude tislelizumab plus chemotherapy offers long-lasting efficacy and favorable patient-reported outcomes, supporting it as a suitable first-line option.
10.1038/s41467-026-77327-0
Sep 21 – Sep 28, 2026
First-Line Retlirafusp Alfa Plus Chemotherapy for Human Epidermal Growth Factor Receptor 2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma: A Randomized, Double-Blind, Phase III Study (RELIGHT).
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This randomized, double-blind, phase III trial evaluated retlirafusp alfa plus CAPOX as first-line treatment for HER2-negative gastric or gastroesophageal junction adenocarcinoma in 731 previously untreated patients. Patients were assigned 1:1 to receive retlirafusp alfa or placebo plus capecitabine and oxaliplatin, with overall survival as the primary endpoint. Retlirafusp alfa significantly improved overall survival in both PD-L1 CPS ≥5 patients (median 16.8 vs 10.4 months; HR 0.53; p<0.0001) and the intention-to-treat population (median 15.8 vs 11.2 months; HR 0.66; p<0.0001), with comparable grade ≥3 treatment-related adverse events (62.6% vs 59.0%). The authors conclude that retlirafusp alfa plus CAPOX represents a first-line treatment option for this population, noting the limitation that chemotherapy alone was the comparator.
10.1200/JCO-25-02933
Biomarker-defined benefit from FLOT plus nivolumab in metastatic gastroesophageal cancer: Extended follow-up and immune-inflammatory markers of the phase II IKF-AIO-moonlight trial.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This study reports extended follow-up and biomarker analyses from the phase II IKF-AIO-moonlight trial (AIO-STO-0417), a prospective clinical trial evaluating FLOT plus nivolumab in metastatic gastroesophageal adenocarcinoma. The trial enrolled 261 patients across five arms; Arm C (n=52) received FLOT+nivo and was analyzed for survival outcomes by PD-L1 CPS, NLR, and MLR, with median follow-up of 12.7 months. Results showed median PFS of 7.0 months and median OS of 14.6 months; CPS≥1, low NLR, and low MLR were associated with numerically longer survival, with combined CPS≥1 and low MLR showing mOS 32.3 vs 7.4 months (p=0.044). The authors conclude that low baseline MLR and positive CPS identify patients with particular benefit from FLOT+nivo that may outweigh the enhanced burden of intensified therapy.
10.1016/j.ejca.2026.117037
Sep 14 – Sep 21, 2026
Pembrolizumab plus chemotherapy as first-line therapy for advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma: 4.5-year follow-up from the randomized phase III KEYNOTE-859 study.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
KEYNOTE-859, a randomized phase III trial, evaluated first-line pembrolizumab plus chemotherapy versus placebo plus chemotherapy in 1579 participants with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. At a median follow-up of 54.8 months, median overall survival was 12.9 months for pembrolizumab plus chemotherapy versus 11.5 months for placebo plus chemotherapy (HR 0.78, 95% CI 0.70-0.86). Longer survival was observed in PD-L1 CPS ≥1 and CPS ≥10 subgroups, with manageable safety profiles. The study confirms that adding pembrolizumab to chemotherapy improves efficacy regardless of PD-L1 status, supporting this combination as a first-line treatment option.
10.1016/j.esmoop.2026.108536
A multicenter phase II trial of ramucirumab plus irinotecan for early recurrence of gastric cancer during or after adjuvant chemotherapy with docetaxel plus S-1 therapy: the RAMIEL trial (OGSG1901).
GASTRIC CANCER · Q1 JOURNAL - RANK #25/147
This prospective, open-label, multicenter phase II trial evaluated ramucirumab plus irinotecan in patients with early recurrence of pathological stage III gastric cancer during or within 6 months after adjuvant docetaxel plus S-1 therapy. Forty-three patients were enrolled across 25 Japanese centers, with 39 included in the analysis after exclusions; treatment consisted of biweekly ramucirumab (8 mg/kg) and irinotecan (150 mg/m²). The primary endpoint of median overall survival was 15.9 months (95% CI: 8.8–42.0; p=0.003), with median progression-free survival of 5.5 months and an objective response rate of 38.5%. The authors concluded that ramucirumab plus irinotecan demonstrated promising efficacy and manageable toxicity, with grade ≥3 adverse events including neutropenia and hypertension each occurring in 25.6% of patients.
10.1007/s10120-026-01799-8
Sintilimab plus Bevacizumab biosimilar IBI305 and chemotherapy as a first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma (SBAGA): a single-arm, phase Ib/II study.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This single-arm, phase Ib/II trial evaluated the efficacy and safety of sintilimab plus the bevacizumab biosimilar IBI305 and CapeOX chemotherapy as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. In phase Ib (N=9), no dose-limiting toxicities were observed; in phase II (N=54 efficacy-evaluable), the primary endpoint ORR was 87.0% (95% CI: 75.1-94.6%), meeting the prespecified target, with a DCR of 98.1%. At a median follow-up of 20.3 months, median PFS was 12.2 months, median DoR was 12.5 months, and median OS was not reached; grade ≥3 treatment-related adverse events occurred in 66% of patients. The authors conclude that the combination demonstrated promising antitumor activity with manageable toxicity, while acknowledging the single-arm design and modest sample size as limitations requiring confirmation in randomized trials.
10.1038/s41467-026-76502-7
Sep 07 – Sep 14, 2026
Safety and efficacy of cisplatin and nab-paclitaxel pressurised intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal carcinomatosis: Nab-PIPAC phase 1b study.
EBIOMEDICINE · Q1 JOURNAL - RANK #13/195TOP-TIER
This phase 1b trial evaluated the safety, tolerability, and pharmacokinetics of combined cisplatin and nab-paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 22 patients with peritoneal carcinomatosis, using a 3+3 dose escalation design for nab-paclitaxel (7.5–70 mg/m²) with fixed cisplatin (10.5 mg/m²). Of 18 patients who received at least one PIPAC, 45 procedures were performed, with 67% completing three cycles; no dose-limiting toxicities occurred, and the most common adverse event was abdominal pain. Median progression-free survival was 3.5 months and median overall survival was 9.4 months, with five gastrointestinal cancer patients surviving beyond one year; pharmacokinetic analysis showed linearity between nab-paclitaxel dose and AUC (R²=0.90). The authors concluded that the combination was safe and well tolerated, warranting further investigation.
10.1016/j.ebiom.2026.106477
Is pembrolizumab as safe and efficient as neoadjuvant treatment in localized dMMR/MSI esophagogastric cancers? Results from the IMHOTEP phase II study.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
The IMHOTEP phase II trial evaluated perioperative pembrolizumab in 41 patients with localized dMMR/MSI esophagogastric cancer, with 36 eligible for efficacy analysis after receiving one to two neoadjuvant infusions (400 mg every 6 weeks). Among 27 operated patients achieving R0 resection, only four (14.8%) attained pathological complete response, though 93% remained progression-free at a median follow-up of 25.8 months. Grade ≥3 treatment-related adverse events occurred in 22% of patients. The authors conclude perioperative pembrolizumab is feasible and safe, warranting further investigation to optimize neoadjuvant immunotherapy duration and design.
10.1016/j.esmoop.2026.108343
Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.
LANCET · Q1 JOURNAL - RANK #1/332TOP-TIER
The MATTERHORN trial, a global, randomised, double-blind, placebo-controlled phase 3 study, evaluated perioperative durvalumab plus FLOT versus placebo plus FLOT in 948 adults with resectable gastric or gastro-oesophageal junction adenocarcinoma across 147 centres. Participants received four cycles of neoadjuvant/adjuvant durvalumab or placebo plus FLOT, followed by ten additional cycles of durvalumab or placebo. Overall survival significantly improved with durvalumab versus placebo (HR 0.78, 95% CI 0.63–0.96; p=0.021), with adverse events leading to death in 1% versus <1%, respectively. Perioperative durvalumab plus FLOT is a new standard treatment option for this population.
10.1016/S0140-6736(26)01254-7
Camrelizumab plus nimotuzumab as second-line therapy for advanced esophageal squamous cell carcinoma: a multicenter phase II study.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This multicenter, single-arm, phase II clinical trial evaluated camrelizumab plus nimotuzumab as second-line therapy for advanced esophageal squamous cell carcinoma (ESCC), enrolling 46 patients who progressed after first-line treatment. The primary endpoint was objective response rate (ORR), with secondary endpoints including disease control rate, progression-free survival (PFS), and overall survival (OS). The confirmed ORR was 32.6% (15/46; 95% CI 19.5-48.0), disease control rate was 82.6% (38/46; 95% CI 68.6-92.2), median PFS was 9.13 months (95% CI 5.95-9.76), and median OS was 12.62 months (95% CI 9.40-15.01). The combination demonstrated encouraging antitumor activity with a manageable safety profile (grade ≥3 adverse events in 8.7%), supporting further investigation of this regimen in advanced ESCC.
10.1136/jitc-2026-015887
Aug 31 – Sep 07, 2026
PD-L1 expression and survival in unresectable/recurrent gastric cancer treated by 1st-line treatment without immune checkpoint inhibitors: JCOG1013A1.
BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This ancillary analysis of the phase III JCOG1013 trial evaluated the prognostic value of PD-L1 expression in 540 patients with unresectable/recurrent gastric cancer receiving first-line chemotherapy without immune checkpoint inhibitors. PD-L1 was assessed in pretreatment tumors using the Dako 28-8 pharmDx assay, calculating CPS and TPS. Univariable analyses showed no significant association of CPS≥5 or TPS≥1% with OS/PFS; multivariable analyses revealed TPS≥1% was independently associated with longer OS (HR 0.78, 95% CI 0.62-0.97; p=0.028) and PFS (HR 0.76, 95% CI 0.62-0.94; p=0.012), whereas CPS≥5 was not (OS: HR 0.86, p=0.127; PFS: HR 0.92, p=0.392). The study concludes TPS≥1% is an independent favorable prognostic factor but not a predictive marker. This is a post-hoc analysis of an interventional trial, meeting inclusion criteria.
10.1038/s41416-026-03607-7
Single-port laparoscopic versus multiple-port laparoscopic combined with thoracoscopic for McKeown esophagectomy: a randomized clinical trial.
SURG ENDOSC · Q1 JOURNAL - RANK #64/312
This randomized clinical trial compared single-port versus multiport laparoscopy combined with thoracoscopy for McKeown esophagectomy in 147 patients (October 2021–December 2023). Primary outcomes were operative time, blood loss, postoperative pain, and lymph node yield; secondary outcomes included complications and recovery. The single-port group showed significantly lower total blood loss (60 vs. 200 mL, P<.001), shorter laparoscopic time (49 vs. 57 min, P=.03), and lower postoperative day 3 pain scores (VAS 2.45 vs. 2.99, P<.001), with similar lymph node yield and complication rates. The authors concluded that single-port laparoscopy reduces blood loss, shortens operative time, and alleviates pain without compromising oncological efficacy or safety.
10.1007/s00464-026-13087-8
Goal-directed nutritional support in preserving muscle mass and optimising recovery in treatment of oesophageal cancer: results of a prospective non-randomised cluster trial.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
This prospective non-randomised cluster trial compared goal-directed nutritional support (GDNS) to usual care in 100 adults with oesophageal cancer undergoing neoadjuvant chemoradiotherapy (CRT) and oesophagectomy. The primary outcome was change in appendicular skeletal muscle index (ASMI) measured by bioelectrical impedance analysis from baseline to 12 months postoperatively, with secondary outcomes of 1-year overall and disease-free survival. ASMI declined during CRT in both groups (GDNS: -2.53±3.43% vs usual care: -3.20±6.92%, P=0.559), recovered preoperatively, and declined by 12 months postoperatively (GDNS: -5.75±4.75% vs usual care: -7.09±7.38%, P=0.598); all comparisons were non-significant, and survival did not differ. The authors concluded that GDNS was associated with smaller, though not statistically significant, muscle loss compared to usual care, highlighting the need for personalised integrated interventions.
10.1007/s00520-026-11153-4
The safety of laparoscopic D2 distal gastrectomy following neoadjuvant chemotherapy for locally advanced gastric cancer patients: a prospective multicenter trial (CLASS-03a).
INT J SURG · Q1 JOURNAL - RANK #3/312TOP-TIER
This prospective, multicenter, single-arm clinical trial (CLASS-03a) conducted at 14 Chinese centers evaluated the safety of laparoscopic D2 distal gastrectomy following neoadjuvant chemotherapy (NAC) in 153 adults with locally advanced gastric cancer (cT3-4a, N0/+, M0). Patients received three cycles of oxaliplatin plus capecitabine prior to surgery. The primary endpoint, postoperative overall morbidity rate, was 20.9% (95%CI: 15.2%-28.0%), with a 0% mortality rate, 100% R0 resection rate, and 1.3% conversion rate. The authors concluded that laparoscopic D2 distal gastrectomy following NAC demonstrates a favorable safety profile for this patient population.
10.1097/JS9.0000000000004531
Older adults with resectable gastric cancer undergoing perioperative chemotherapy or preoperative chemoradiotherapy plus perioperative chemotherapy: A secondary analysis of the AGITG TOPGEAR phase III trial.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This secondary analysis of the phase III TOPGEAR trial evaluated treatment adherence, adverse events, and survival in older (≥70 years) versus younger adults with resectable gastric cancer. Patients were randomized to perioperative chemotherapy alone or with preoperative chemoradiotherapy. Of 574 patients, 135 (24%) were older, who more frequently required preoperative dose modifications (chemoradiotherapy: 55% vs 35%, p=0.004). Grade ≥3 adverse events were similar, but older adults had more hematologic toxicity and diarrhea. Overall survival was comparable (HR 0.86, 95% CI 0.58-1.26 for chemoradiotherapy; HR 0.75, 95% CI 0.51-1.11 for chemotherapy).
10.1016/j.ejca.2026.117005
Aug 24 – Aug 31, 2026
Repeated normothermic intraperitoneal paclitaxel perfusion via videolaparoscopy (RIPPENC-VLP) combined with CAPOX for gastric cancer with positive cytology or limited peritoneal metastasis: A prospective phase II study.
EJSO-EUR J SURG ONC · Q1 JOURNAL - RANK #54/312
This prospective phase II study evaluated a response-adapted strategy combining repeated normothermic intraperitoneal paclitaxel perfusion via videolaparoscopy (RIPPENC-VLP) with systemic CAPOX chemotherapy in 35 patients with gastric adenocarcinoma and positive peritoneal cytology or limited peritoneal metastasis (PCI ≤10). Patients received a mean of 2.7 treatment cycles, with serial quantification of free peritoneal tumor cells via flow cytometry. Cytological conversion (CY+ to CY-) occurred in 27 patients (77.1%), enabling secondary gastrectomy in all converted patients, with a median overall survival of 24.7 months for the entire cohort. The authors concluded that this neoadjuvant intraperitoneal plus systemic therapy approach was feasible and associated with high conversion and resection rates, suggesting it may enable conversion surgery in selected patients with low-volume gastric peritoneal metastasis.
10.1016/j.ejso.2026.112100
Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G.
GASTRIC CANCER · Q1 JOURNAL - RANK #25/147
This phase II clinical trial (WJOG10517G) prospectively evaluated mFOLFOX6 chemotherapy in 51 HER2-negative, chemotherapy-naive advanced gastric cancer patients with severe peritoneal metastases, defined as massive ascites and/or inadequate oral intake. The primary endpoint was overall survival (OS), with secondary endpoints including ascites response and oral intake improvement. Median OS was 7.4 months (lower one-sided 95% CI 6.5), median PFS was 3.8 months, ascites response rate was 36% (9/25), and oral intake improvement was 46% (15/33). Grade 3-4 neutropenia occurred in 51% of patients, with no treatment-related deaths; propensity-score weighted OS hazard ratios versus FL and FLTAX were 0.76 (95% CI 0.56-1.03) and 0.87 (95% CI 0.64-1.18), concluding mFOLFOX6 is tolerable and a potential treatment option.
10.1007/s10120-026-01790-3
Primary outcomes of a phase II trial of laparoscopic/robotic total gastrectomy with spleen-preserving splenic hilar dissection for locally advanced proximal gastric cancer involving the greater curvature (JCOG1809).
GASTRIC CANCER · Q1 JOURNAL - RANK #25/147
This multicenter phase-II trial (JCOG1809) prospectively evaluated the safety and efficacy of laparoscopic/robotic spleen-preserving splenic hilar dissection (LR-SHD) with total gastrectomy in 85 eligible patients with cT2-4a locally advanced proximal gastric cancer involving the greater curvature. The primary endpoint, postoperative pancreatic fistula and/or intra-abdominal abscess (Grade ≥ III), occurred in 1.2% (1/81; 80% CI 0.1-4.7%), significantly lower than the prespecified 16% threshold (one-sided p<0.0001). Overall Grade ≥ III complications occurred in 9.9% (8/81), with no treatment-related mortality. The authors concluded that LR-SHD is safe and feasible when performed by experienced surgeons and is promising for this patient population.
10.1007/s10120-026-01792-1
Aug 17 – Aug 24, 2026
Atezolizumab with or without tiragolumab in unresectable esophageal squamous cell carcinoma following definitive concurrent chemoradiotherapy (SKYSCRAPER-07): a randomised, phase III study.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This phase III, global, randomised, placebo-controlled trial (SKYSCRAPER-07) evaluated atezolizumab with or without tiragolumab versus placebo in 760 adults with unresectable esophageal squamous cell carcinoma following definitive chemoradiotherapy. Patients were randomised 1:1:1 to atezolizumab plus tiragolumab, atezolizumab plus placebo, or placebo, with primary endpoints of investigator-assessed progression-free survival (INV-PFS) and overall survival (OS). At a median follow-up of 25 months, atezolizumab plus tiragolumab did not statistically improve INV-PFS (HR 0.82, p=0.0947) or OS (HR 0.91, p=0.4772), but atezolizumab plus placebo significantly improved both OS (HR 0.69, p=0.0085) and INV-PFS (HR 0.74) versus placebo. The study did not meet its primary endpoint, but demonstrated clinically meaningful survival benefits for atezolizumab monotherapy in this setting.
10.1016/j.annonc.2026.07.413
Local Regrowth After Neoadjuvant Chemoradiotherapy and Active Surveillance for Esophageal Cancer: An Analysis of Surgical Specimens From the SANO Trial.
ANN SURG · Q1 JOURNAL - RANK #10/312
This retrospective cohort study analyzed surgical specimens from 75 patients with esophageal cancer who achieved complete clinical response after neoadjuvant chemoradiotherapy and underwent active surveillance within the SANO trial, subsequently developing regrowth and undergoing surgery. The primary outcome was the anatomic layer(s) of cancer regrowth within the esophageal wall, assessed by two pathologists. Results showed cancer cells in the mucosal layer in 68/75 patients (91%), with tumor confined to mucosa in only 5%, while submucosal involvement was present in 88%, proper muscle layer in 71%, and surrounding stroma in 61% of specimens; 4 patients had lymph node involvement. The authors conclude that regrowth predominantly involves mucosa and submucosa, supporting endoscopy for detection, but surgery remains recommended due to risk of undetected nodal disease.
10.1097/SLA.0000000000007179
Paclitaxel oral solution versus paclitaxel injection as second-line therapy for advanced gastric cancer: a multicenter, open-label, randomized phase III trial.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This multicenter, open-label, randomized phase III trial compared oral paclitaxel with intravenous paclitaxel as second-line therapy for advanced gastric cancer. Patients with unresectable, recurrent, or metastatic disease who progressed after first-line fluoropyrimidine-based therapy were randomly assigned 1:1 to receive oral paclitaxel (200 mg/m² twice daily on days 1, 8, 15 of a 28-day cycle) or injection (175 mg/m² on day 1 of a 21-day cycle). Among 536 randomized patients, the oral formulation showed significantly improved overall survival (9.13 vs. 6.54 months; HR 0.770, 95.5% CI 0.635-0.934, P=0.006) and noninferior progression-free survival (3.02 vs. 2.89 months; HR 0.894, 95% CI 0.719-1.112, P=0.311), with a favorable safety profile and rare treatment-related fatal events (1.5% vs. 1.1%). The authors conclude that oral paclitaxel is a viable alternative for second-line gastric cancer treatment.
10.1016/j.esmoop.2026.108312