Biliary Tract Cancer
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Jun 01 – Jun 08, 2026
Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase 3 FIGHT-302 Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase 3, randomized, global trial (FIGHT-302) evaluated pemigatinib as first-line therapy in adults with advanced FGFR2-rearranged cholangiocarcinoma. One hundred sixty-seven patients were randomized to pemigatinib (13.5 mg daily) or chemotherapy (gemcitabine/cisplatin), with crossover allowed. Median progression-free survival was 8.3 vs 6.8 months (HR 0.58; p=0.0078), objective response rate 47% vs 15%, and median overall survival 24.4 vs 25.0 months. Pemigatinib demonstrated superior PFS versus chemotherapy with consistent safety, supporting its use as first-line targeted therapy for this population.
10.1200/JCO-26-00788
May 18 – May 25, 2026
First-Line Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-966 Study.
ADV THER · Q1 JOURNAL - RANK #82/352
This randomized, double-blind, phase 3 Chinese subgroup analysis of the global KEYNOTE-966 trial assessed first-line pembrolizumab 200 mg every 3 weeks plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin in 158 adults with previously untreated advanced biliary tract cancer. After a median follow-up of 20.5 months, median overall survival was 14.1 months for pembrolizumab and 9.9 months for placebo (HR 0.74, 95% CI 0.51-1.08); median progression-free survival was 5.6 versus 5.7 months (HR 0.83). Objective response rate reached 36.0% versus 28.9%, and median duration of response was 10.2 versus 5.7 months, respectively. Grade 3/4 treatment-related adverse events occurred in 71.6% and 70.7% of patients, with no treatment-related deaths; authors conclude pembrolizumab added to chemotherapy yields clinically meaningful survival improvement and acceptable safety in Chinese patients with advanced biliary tract cancer.
10.1007/s12325-026-03578-4
May 11 – May 18, 2026
The multi-kinase inhibitor tinengotinib as monotherapy or combined with atezolizumab in advanced solid tumors: a phase Ib/II trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This phase Ib/II trial (NCT05253053) evaluated the safety, tolerability, dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and efficacy of the multi-kinase inhibitor tinengotinib as monotherapy (Arm A, n=53) and in combination with atezolizumab (Arm B, n=31) in patients with advanced solid tumors and biliary tract cancer, respectively. The study used a dose-escalation (3+3 design) phase followed by a dose-expansion phase. Primary endpoints were achieved, as tinengotinib was well tolerated with no DLTs and undetermined MTD; efficacy was demonstrated with overall response rates (ORRs) of 16.7% (monotherapy) and 22.6% (combination). Subgroup analysis showed notable efficacy in cholangiocarcinoma, with monotherapy showing 66.7% ORR in patients harboring FGFR2 fusion and combination therapy achieving a 20.0% ORR and a 75.0% disease control rate in prior immune checkpoint inhibitor-treated cholangiocarcinoma patients.
10.1038/s41467-026-72541-2
Apr 27 – May 04, 2026
Doublet versus triplet therapy in Indian patients with locally advanced & metastatic gall bladder cancer: a randomised trial.
SCI REP-UK · Q1 JOURNAL - RANK #25/135
This randomized, prospective clinical trial enrolled 60 Indian patients with unresectable locally advanced or metastatic gallbladder cancer to compare standard doublet chemotherapy (gemcitabine + cisplatin) with an investigational triplet (gemcitabine + cisplatin + nab-paclitaxel). Patients were treated for six cycles and followed every six months for two years; primary outcomes were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), with adverse events also catalogued. The triplet arm achieved a markedly higher ORR (61.9 % vs 13.3 %; p = 0.004) and longer median PFS (7.6 months, 95 % CI 3.9–11.2) than the doublet arm (4.5 months, 95 % CI 4.0–4.9; p ≤ 0.05), without an increase in grade 3 toxicities. The authors conclude that adding nab-paclitaxel to gemcitabine–cisplatin significantly improves tumor response and PFS in advanced gallbladder cancer while maintaining tolerable safety.
10.1038/s41598-026-36231-9
Apr 20 – Apr 27, 2026
Nivolumab and ipilimumab combination treatment in patients with advanced intrahepatic cholangiocarcinoma and gallbladder cancer: Results from the phase II MoST-CIRCUIT trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-arm, non-randomized phase II trial (MoST-CIRCUIT) prospectively evaluated nivolumab and ipilimumab in 60 patients with advanced intrahepatic cholangiocarcinoma (iCCA) and gallbladder cancer (GBC) who had a maximum of one prior systemic therapy. Patients received four doses of nivolumab 3mg/kg and ipilimumab 1mg/kg every three weeks, followed by nivolumab 480mg every four weeks for 96 weeks, with response assessed per RECIST 1.1. The objective response rate was 12% (2% complete response, 10% partial response), 6-month progression-free survival was 27%, and median overall survival was 7 months; in the immunotherapy-naïve subgroup, ORR was 19%. The authors concluded that efficacy was limited overall but encouraging in GBC, recommending further focus on GBC patients in future trials.
10.1158/1078-0432.CCR-25-4009
Apr 13 – Apr 20, 2026
Phase II trial of hepatic arterial infusion chemotherapy plus bevacizumab and toripalimab for advanced biliary tract cancers: efficacy, safety, and exploratory analysis.
HEPATOBIL SURG NUTR · Q1 JOURNAL - RANK #7/312
This phase II clinical trial evaluated hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin and 5-fluorouracil combined with bevacizumab and toripalimab as first-line treatment for advanced biliary tract cancers in 32 treatment-naïve participants. The primary endpoint was objective response rate using Immune-Modified RECIST criteria, with secondary endpoints of progression-free survival, overall survival, and safety. The objective response rate was 84.38%, disease control rate was 96.88%, median progression-free survival was 13.20 months (95% CI: 8.93-17.47), and median overall survival was 19.0 months (95% CI: 12.22-25.78), with grade 3+ adverse events occurring in 31.25% of participants. The authors concluded this combination may serve as an improved first-line treatment requiring verification through randomized controlled trials.
10.21037/hbsn-24-463
Apr 06 – Apr 13, 2026
Preoperative Biliary Drainage with Metal Stent Versus Early Surgery in Patients with Pancreatic Cancer: A Randomized Clinical Trial.
ANN SURG ONCOL · Q1 JOURNAL - RANK #39/312
This randomized clinical trial aimed to compare the safety of preoperative biliary drainage (PBD) using a self-expanding metal stent (SEMS) to early surgery in patients with resectable pancreatic or periampullary cancer experiencing biliary obstruction and scheduled for pancreaticoduodenectomy. The study enrolled 284 patients across 11 centers in 9 countries, randomizing them to either PBD or early surgery; the primary endpoint was the proportion of patients with at least one serious adverse event (SAE) within 120 days post-randomization, and key secondary endpoints included SEMS insertion rate, curative-intent resection rate, and all-cause mortality. Results showed SAE rates of 29.0% (40/138) for PBD and 26.5% (36/136) for early surgery, with a between-group difference of 2.5% (upper 95% confidence limit 11.7%, P = 0.011 for noninferiority); mortality rates were similar between groups (7.9% PBD vs. 8.0% early surgery). The authors concluded that PBD with SEMS is noninferior to early surgery regarding safety in this patient population.
10.1245/s10434-026-19546-9