80 completed, 58 recruiting, 45 unknown, 22 terminated. 146 Phase 2, 51 Phase 1, 26 Phase 3, 21 Not applicable, 1 Early Phase 1.
Follow Biliary Tract Cancer: new trials by email Literature Review of Biliary Tract Cancer trials Research Report on Biliary Tract Cancer
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract Tumors Zanidatamab - Biliary Tract Cancer | Phase 2 | Not yet recruiting | Anhui Provincial Hospital | 15 | 2026-11-30 | 2026-10-01 |
| A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous ABBV-253 Moves Through the Body in Adult Participants With Advanced Solid Tumors ABBV-253 - Advanced Solid Tumors, Non-Small Cell Lung Cancer | Phase 1 | Recruiting | AbbVie | 130 | 2026-09-14 | 2026-10-16 |
| Study of Occupational Risk Factors for Biliary and Pancreatic Cancers Biliary Tract Cancer, Pancreatic Cancer | Not yet recruiting | Centre Hospitalier Intercommunal Creteil | 210 | 2026-08-01 | 2026-06-25 | |
| A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure BL-M07D1, Oxaliplatin, Calcium levofolinate - Biliary Tract Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 398 | 2026-07-07 | 2026-07-24 |
| A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01) BL-B01D1, Oxaliplatin, Calcium levofolinate - Biliary Tract Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 538 | 2026-06-29 | 2026-07-24 |
| Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer Futibatinib, Zimberelimab, Durvalumab - Biliary Tract Cancer | Phase 3 | Recruiting | Taiho Pharmaceutical Co., Ltd. | 784 | 2026-06-24 | 2026-07-17 |
| Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer HAIC Combined Regimen Treatment Group - Biliary Tract Cancer | Phase 1 / Phase 2 | Recruiting | West China Hospital | 20 | 2026-06-01 | 2026-07-13 |
| Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies Neoadjuvant therapy followed by surgery - Biliary Tract Cancer | Phase 2 | Not yet recruiting | Sir Run Run Shaw Hospital | 34 | 2026-05-30 | 2026-05-20 |
| Adebrelimab Plus S-1 for Resected Cholangiocarcinoma Adebrelimab, S-1 - Cholangiocarcinoma, Biliary Tract Cancer | Phase 2 | Not yet recruiting | Xingjun Guo | 40 | 2026-04-21 | 2026-05-01 |
| A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer SHR-A1904 for Injection - Biliary Tract Cancer | Phase 2 | Recruiting | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 151 | 2026-03-25 | 2026-03-31 |
| Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer EB-HC01 dual-target CARNK cells, Fludarabine, Cyclophosphamide - Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma | Phase 1 / Phase 2 | Recruiting | Beijing Biotech | 30 | 2026-03-02 | 2026-06-11 |
| Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer Sintilimab, Irinotecan Hydrochloride Liposome Injection (II), Oxaliplatin - Biliary Tract Cancer | Phase 2 | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | 54 | 2026-01-14 | 2026-09-21 |
| Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil, Leucovorin - Biliary Tract Cancer | Phase 2 | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | 31 | 2026-01-08 | 2026-09-01 |
| Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer HAIC, Gemcitabine plus Cisplatin, Adebrelimab - Biliary Tract Cancer | Phase 2 | Recruiting | Air Force Military Medical University, China | 124 | 2025-12-10 | 2026-05-06 |
| A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin - Biliary Tract Cancer | Phase 3 | Recruiting | AstraZeneca | 1100 | 2025-12-04 | 2026-09-28 |
| Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer Trifluridine/tipiracil, Oxaliplatin - Biliary Tract Cancer, Biliary Tract Neoplasms | Phase 2 | Suspended | Case Comprehensive Cancer Center | 27 | 2025-12-01 | 2026-10-20 |
| Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients Ivonescimab, FOLFOX regimen - Biliary Tract Cancer | Phase 2 | Recruiting | UNICANCER | 72 | 2025-10-09 | 2026-08-28 |
| ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer Blood Sampling for ctDNA Analysis - Biliary Tract Cancer | Recruiting | CHA University | 100 | 2025-09-01 | 2026-03-18 | |
| Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS)) - Biliary Tract Cancer | Recruiting | CHA University | 200 | 2025-09-01 | 2026-03-18 | |
| Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer Disitamab Vedotin, Lenvatinib, Pembrolizumab - Biliary Tract Cancer, Disitamab Vedotin | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 65 | 2025-08-30 | 2025-09-08 |
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Biliary Tract Neoplasms (246) · Cholangiocarcinoma (52) · Gallbladder Neoplasms (37) · Pancreatic Neoplasms (30) · Stomach Neoplasms (26) · Colorectal Neoplasms (21) · Carcinoma, Non-Small-Cell Lung (18) · Liver Neoplasms (14) · Carcinoma, Hepatocellular (13) · Esophageal Neoplasms (12) · Neoplasm Metastasis (12) · Ovarian Neoplasms (12) · Bile Duct Neoplasms (9) · Carcinoma, Transitional Cell (9) · Endometrial Neoplasms (9)
Neoplasms by Site (246) · Biliary Tract Diseases (245) · Digestive System Diseases (245) · Digestive System Neoplasms (245) · Neoplasms (239) · Neoplasms by Histologic Type (78) · Neoplasms, Glandular and Epithelial (73) · Carcinoma (72) · Adenocarcinoma (64) · Gastrointestinal Diseases (42) · Endocrine Gland Neoplasms (40) · Endocrine System Diseases (40) · Gallbladder Diseases (39) · Gastrointestinal Neoplasms (37) · Pancreatic Diseases (30)
Gemcitabine (55) · Cisplatin (44) · Capecitabine (23) · Oxaliplatin (21) · Fluorouracil (20) · Leucovorin (16) · pembrolizumab (16) · durvalumab (15) · S 1 (combination) (12) · Bevacizumab (10) · lenvatinib (10) · Irinotecan (9) · Nivolumab (6) · 130-nm albumin-bound paclitaxel (5) · Blood Specimen Collection (5)
AstraZeneca (12) · Kansai Hepatobiliary Oncology Group (10) · Peking Union Medical College Hospital (7) · Samsung Medical Center (7) · Massachusetts General Hospital (6) · Shanghai Zhongshan Hospital (5) · CHA University (4) · Sun Yat-sen University (4) · ASLAN Pharmaceuticals (3) · Asan Medical Center (3) · Eli Lilly and Company (3) · Seoul National University Hospital (3) · Tongji Hospital (3) · University of Michigan Rogel Cancer Center (3) · AIO-Studien-gGmbH (2)
China (85) · United States (68) · South Korea (48) · Japan (33) · United Kingdom (25) · Spain (24) · Germany (22) · France (21) · Italy (21) · Taiwan (19) · Canada (13) · Australia (11) · Turkey (Türkiye) (11) · Belgium (10) · Poland (9)
Hiroaki Nagano, MD, PhD (4) · Vaibhav Sahai, MBBS, MS (3) · Changhoon Yoo, MD (2) · Do-Youn Oh, MD, PhD (2) · Etsuro Hatano, MD, PhD (2) · Hai-Tao Zhao, M.D. (2) · Hong Jae Chon, MD. PhD (2) · Ming Kuang, PhD (2) · Afshin Dowlati, MD (1) · Aiwu R He, MD (1)
PMID 20375404, PMID 25477010, PMID 32461347, PMID 33198671, PMID 33798493, PMID 19097774, PMID 19932054, PMID 21561347, PMID 22537432, PMID 23043667, PMID 24146220, PMID 24581682, PMID 24614947, PMID 24681130, PMID 25538178, PMID 25794066, PMID 27114433, PMID 27861546, PMID 28818953, PMID 29168120, PMID 29408986, PMID 29417360, PMID 29433850, PMID 29653120, PMID 29663291, PMID 29733511, PMID 29853658, PMID 30207593, PMID 30261853, PMID 30319983, PMID 30575325, PMID 30643463, PMID 30671808, PMID 30805831, PMID 30914290, PMID 30993651, PMID 30998813, PMID 31014381, PMID 31109809, PMID 31285372, PMID 31301962, PMID 31312030, PMID 31442395, PMID 31451841, PMID 31646981, PMID 32059704, PMID 32112738, PMID 32183229, PMID 32352498, PMID 32374623
2023 (7), 2015 (3), 2016 (3), 2018 (2), 2019 (2), 2017 (1), K01AT008219 (1), P30CA068485 (1), R01CA252211 (1)