6 terminated, 5 recruiting, 3 unknown, 1 approved for marketing. 9 Phase 2, 6 Phase 1, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Recruiting 4, Unknown 3, Terminated 2 |
| Phase 1 | 6 | Terminated 2, Unknown 2, Recruiting 1, Suspended 1 |
| Phase 3 | 5 | Terminated 2, Completed 1, Not yet recruiting 1, Recruiting 1 |
Follow Advanced Cholangiocarcinoma: new trials by email Literature Review of Advanced Cholangiocarcinoma trials Research Report on Advanced Cholangiocarcinoma
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 |
|---|---|---|---|---|---|---|
| Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations TT-00420 (tinengotinib), Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine - Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma | Phase 3 | Not yet recruiting | TransThera Sciences (Nanjing), Inc. | 138 | 2026-01-01 | 2026-01-09 |
| Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion Pemigatinib, Atezolizumab, Bevacizumab - Advanced Cholangiocarcinoma, FGFR2 Fusion | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 25 | 2024-11-19 | 2026-08-17 |
| NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma Biospecimen Collection, Computed Tomography, Heat Shock Factor 1 Pathway Inhibitor NXP800 - Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma | Phase 1 | Terminated | Mayo Clinic | 7 | 2024-05-31 | 2025-12-22 |
| Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma Lenvatinib, tislelizumab, gemcitabine and cisplatin, Gemcitabine and cisplatin - Advanced Cholangiocarcinoma | Phase 3 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 80 | 2023-09-01 | 2025-02-10 |
| At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer Clinical Encounter, Home Health Encounter, Quality-of-Life Assessment - Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma | Phase 2 | Recruiting | Mayo Clinic | 220 | 2023-08-23 | 2026-04-20 |
| Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement TAS-120 - Advanced Cholangiocarcinoma, FGFR2 Fusions | Phase 2 | Recruiting | Taiho Oncology, Inc. | 120 | 2023-07-05 | 2026-09-01 |
| AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging - Advanced Cholangiocarcinoma, Advanced Hepatocellular Carcinoma | Phase 1 | Suspended | University of Southern California | 36 | 2023-03-29 | 2026-08-17 |
| IMM2902 in Patients With Advanced Solid Tumors Expressing HER2 IMM2902 - Advanced Solid Tumor, Advanced Lung Cancer | Phase 1 / Phase 2 | Unknown | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | 105 | 2022-02-15 | 2023-04-10 |
| Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma Lenvatinib, tislelizumab, gemcitabine and cisplatin, gemcitabine and cisplatin - Advanced Cholangiocarcinoma | Phase 2 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 100 | 2022-01-31 | 2025-02-10 |
| Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma Cisplatin, Gemcitabine, Ivosidenib - Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma | Phase 1 | Terminated | Academic and Community Cancer Research United | 8 | 2021-01-25 | 2024-05-06 |
| Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Futibatinib, Cisplatin, Gemcitabine - Advanced Cholangiocarcinoma, FGFR2 Gene Rearrangements | Phase 3 | Terminated | Taiho Oncology, Inc. | 10 | 2021-01-06 | 2025-02-07 |
| Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations BGJ398, Gemcitabine, Cisplatin - Advanced Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 3 | Terminated | QED Therapeutics, a BridgeBio company | 48 | 2019-12-27 | 2024-05-08 |
| Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma Toripalimab, Gemcitabine, 5- fluorine pyrimidine - Advanced Cholangiocarcinoma | Phase 2 | Unknown | Jiangmen Central Hospital | 30 | 2019-07-13 | 2019-07-16 |
| Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma Anlotinib, TQB2450 - Advanced Cholangiocarcinoma | Phase 1 / Phase 2 | Unknown | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 42 | 2019-06-24 | 2019-10-30 |
| Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron Pembrolizumab, Sylatron - Advanced Cholangiocarcinoma | Phase 2 | Terminated | Aiwu Ruth He, MD | 4 | 2017-07-05 | 2022-02-16 |
| Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) AG-120, Placebo - Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma | Phase 3 | Completed | Institut de Recherches Internationales Servier | 187 | 2017-02-20 | 2024-08-20 |
| A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma BGJ398 (infigratinib) - Advanced Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 2 | Terminated | QED Therapeutics, a BridgeBio company | 143 | 2014-07-23 | 2023-07-03 |
| Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements TAS-120 - Advanced Cholangiocarcinoma | Approved for marketing | Taiho Oncology, Inc. | 2026-03-10 |
Cholangiocarcinoma (10) · Carcinoma, Hepatocellular (1) · Cirrhosis, Familial, with Pulmonary Hypertension (1) · Klatskin Tumor (1) · Multiple Myeloma (1) · Myelodysplastic Syndromes (1)
Neoplasms (12) · Neoplasms by Histologic Type (12) · Adenocarcinoma (11) · Carcinoma (11) · Neoplasms, Glandular and Epithelial (11) · Blood Protein Disorders (1) · Bone Marrow Diseases (1) · Cardiovascular Diseases (1) · Digestive System Diseases (1) · Digestive System Neoplasms (1) · Hematologic Diseases (1) · Hemic and Lymphatic Diseases (1) · Hemorrhagic Disorders (1) · Hemostatic Disorders (1) · Immune System Diseases (1)
Gemcitabine (6) · Cisplatin (5) · futibatinib (3) · Fluorouracil (2) · Magnetic Resonance Spectroscopy (2) · Specimen Handling (2) · infigratinib (2) · ivosidenib (2) · lenvatinib (2) · pemigatinib (2) · tislelizumab (2) · 1,2-diaminocyclohexaneplatinum II citrate (1) · Bevacizumab (1) · Capecitabine (1) · Home Care Services (1)
Taiho Oncology, Inc. (3) · Mayo Clinic (2) · QED Therapeutics, a BridgeBio company (2) · Second Affiliated Hospital, Zhejiang University, School of Medicine (2) · Academic and Community Cancer Research United (1) · Aiwu Ruth He, MD (1) · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (1) · ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (1) · Institut de Recherches Internationales Servier (1) · Jiangmen Central Hospital (1) · M.D. Anderson Cancer Center (1) · TransThera Sciences (Nanjing), Inc. (1) · University of Southern California (1)
United States (12) · China (8) · Italy (5) · South Korea (5) · Spain (5) · United Kingdom (4) · Australia (3) · Belgium (3) · France (3) · Germany (3) · Portugal (3) · Taiwan (3) · Thailand (3) · Argentina (2) · Brazil (2)
Aiwu R. He, MD PhD (1) · Anthony B El-Khoueiry, MD (1) · Mitesh J. Borad, MD (1) · Roxana S. Dronca, MD (1) · Shubham Pant (1) · Sunyoung Lee, MD,PHD (1)
PMID 25763789, PMID 29182496, PMID 32580579, PMID 34358484, PMID 34554208, PMID 35491432, PMID 38278871, PMID 40717483, PMID 41646284, PMID 41678089
2018 (1), 2019 (1), 2023 (1), P30CA014089 (1), P30CA015083 (1)