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ID | DOID:4607 |
Name | biliary tract cancer |
Definition | A hepatobiliary system cancer that results_in malignant growth located_in the gallbladder or located_in the bile duct. |
Source | DiseaseOntology.org |
Alt Ids | DOID:8092 |
Path | disease disease of cellular proliferation cancer organ system cancer gastrointestinal system cancer hepatobiliary system cancer biliary tract cancer |
Molecular Profile | Therapy | Indication/Tumor Type | Response Type | Profile Response Detail |
---|---|---|---|---|
NRAS mutant | Binimetinib | biliary tract cancer | predicted - sensitive | detail... |
FGFR2 fusion | Futibatinib | biliary tract cancer | predicted - sensitive | detail... |
CDKN2A loss | Palbociclib | biliary tract cancer | no benefit | detail... |
CDKN2A mutant | Palbociclib | biliary tract cancer | no benefit | detail... |
BRAF V600E | Dabrafenib + Trametinib | biliary tract cancer | sensitive | detail... |
MSH6 negative | Pembrolizumab | biliary tract cancer | sensitive | detail... |
MLH1 negative | Pembrolizumab | biliary tract cancer | sensitive | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01828034 | Phase Ib/II | Binimetinib + Cisplatin + Gemcitabine | First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma | Completed | USA | 0 |
NCT01853618 | Phase I | Tremelimumab | Tremelimumab With Chemoembolization or Ablation for Liver Cancer | Completed | USA | 0 |
NCT02034110 | Phase II | Dabrafenib + Trametinib | Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 6 |
NCT02053376 | Phase II | Regorafenib | A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy | Completed | USA | 0 |
NCT02091141 | Phase II | Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab | My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors | Completed | USA | 0 |
NCT02105350 | Phase I | Binimetinib + Gemcitabine + Oxaliplatin | A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer | Withdrawn | 0 | |
NCT02151084 | Phase II | Cisplatin + Gemcitabine + Selumetinib | A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer | Active, not recruiting | CAN | 0 |
NCT02240238 | Phase Ib/II | Gemcitabine + NC-6004 | Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer | Completed | USA | ITA | 3 |
NCT02265341 | Phase II | Ponatinib | Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions | Completed | USA | 0 |
NCT02268825 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Pembrolizumab | Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers | Terminated | USA | 0 |
NCT02451553 | Phase I | Afatinib Capecitabine | Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer | Completed | USA | 0 |
NCT02452970 | Phase II | RRx-001 Cisplatin + Gemcitabine | RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy (EPIC) | Terminated | USA | 0 |
NCT02454972 | Phase II | Lurbinectedin | Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors | Completed | USA | ITA | GBR | FRA | ESP | DEU | BEL | 2 |
NCT02576431 | Phase II | Larotrectinib | A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors (NAVIGATE) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 22 |
NCT02703714 | Phase II | Pembrolizumab + Sargramostim | Pembrolizumab and GM-CSF in Biliary Cancer | Completed | USA | 0 |
NCT02711553 | Phase II | Ramucirumab Merestinib Cisplatin + Gemcitabine | A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer | Active, not recruiting | USA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 11 |
NCT02795156 | Phase II | Cabozantinib Afatinib Regorafenib | Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations | Completed | USA | 0 |
NCT02821754 | Phase Ib/II | Durvalumab + Tremelimumab | A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) | Completed | USA | 0 |
NCT02897375 | Phase I | Cisplatin + Palbociclib Carboplatin + Palbociclib | Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors | Completed | USA | 0 |
NCT03093870 | Phase II | Capecitabine + Varlitinib Capecitabine | Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer | Completed | USA | ESP | AUS | 8 |
NCT03101566 | Phase II | Cisplatin + Gemcitabine + Nivolumab Ipilimumab + Nivolumab | Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer | Completed | USA | 0 |
NCT03111732 | Phase II | Capecitabine + Oxaliplatin + Pembrolizumab | Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC) | Completed | USA | 0 |
NCT03260712 | Phase II | Cisplatin + Gemcitabine + Pembrolizumab | Pembrolizumab in Biliary Tract Cancer | Completed | GBR | ESP | DEU | 0 |
NCT03337087 | Phase Ib/II | Fluorouracil + Leucovorin + MM-398 + Rucaparib | Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer | Active, not recruiting | USA | 0 |
NCT03410927 | Phase Ib/II | TAS0728 | A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities | Terminated | USA | GBR | FRA | ESP | 0 |
NCT03482102 | Phase II | Durvalumab + Tremelimumab | Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer | Recruiting | USA | 0 |
NCT03639935 | Phase II | Nivolumab + Rucaparib | Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum | Active, not recruiting | USA | 0 |
NCT03684811 | Phase Ib/II | Cisplatin + Gemcitabine + Olutasidenib Azacitidine + Olutasidenib Olutasidenib Nivolumab + Olutasidenib | A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation | Completed | USA | GBR | FRA | ESP | AUS | 1 |
NCT03704480 | Phase II | Durvalumab + Tremelimumab | Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy (IMMUNO-BIL) | Recruiting | FRA | 0 |
NCT03768531 | Phase II | Cabiralizumab + Nivolumab Nivolumab | Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer | Withdrawn | 0 | |
NCT03785873 | Phase Ib/II | Fluorouracil + Irinotecan + Leucovorin + Nivolumab | Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer | Active, not recruiting | USA | 0 |
NCT03833661 | Phase II | Bintrafusp alfa | M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) | Completed | USA | ITA | GBR | FRA | ESP | 4 |
NCT03875235 | Phase III | Cisplatin + Gemcitabine Cisplatin + Durvalumab + Gemcitabine | A Global Phase III Study of Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) | Active, not recruiting | USA | ITA | GBR | FRA | 13 |
NCT03929666 | Phase II | Cisplatin + Gemcitabine Cisplatin + Fluorouracil + ZW25 Capecitabine + Oxaliplatin + ZW25 Fluorouracil + Leucovorin + Oxaliplatin + ZW25 Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin + ZW25 | A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer | Recruiting | USA | CAN | 2 |
NCT03936959 | Phase I | LY3434172 | A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer | Completed | USA | FRA | BEL | AUS | 1 |
NCT03964233 | Phase I | BI 907828 + Ezabenlimab + Miptenalimab BI 907828 + Ezabenlimab BI 907828 | A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With Ezabenlimab With or Without BI 754111 | Recruiting | USA | GBR | FRA | ESP | DEU | BEL | AUS | 4 |
NCT03991832 | Phase II | Durvalumab + Olaparib | Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors (SOLID) | Recruiting | CAN | 0 |
NCT04003896 | Phase II | Abemaciclib | A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy | Terminated | USA | 0 |
NCT04066491 | Phase II | Cisplatin + Gemcitabine Bintrafusp alfa + Cisplatin + Gemcitabine | Gemcitabine Plus Cisplatin With or Without M7824 in Participants With 1L Biliary Tract Cancer (BTC) | Terminated | USA | ITA | GBR | FRA | ESP | DEU | AUS | 8 |
NCT04163900 | Phase III | Cisplatin + NUC-1031 Cisplatin + Gemcitabine | Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer (NuTide:121) | Terminated | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 7 |
NCT04203160 | Phase Ib/II | Cisplatin + Gemcitabine Cisplatin + CPI-613 + Gemcitabine | Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) | Recruiting | USA | 0 |
NCT04238637 | Phase II | Durvalumab Durvalumab + Tremelimumab | Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC) | Recruiting | DEU | 0 |
NCT04338685 | Phase I | RO7119929 + Tocilizumab | A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases | Completed | USA | ESP | 4 |
NCT04466891 | Phase II | ZW25 | A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (HERIZON-BTC-01) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | CAN | 3 |
NCT04482309 | Phase II | Trastuzumab deruxtecan | A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) | Active, not recruiting | USA | ITA | GBR | ESP | CAN | BEL | AUS | 8 |
NCT04491942 | Phase I | BAY1895344 + Cisplatin BAY1895344 + Cisplatin + Gemcitabine | Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer | Recruiting | USA | CAN | 0 |
NCT04566133 | Phase II | Hydroxychloroquine + Trametinib | Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). | Terminated | USA | 0 |
NCT04578444 | Expanded access | ZW25 | An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer | Available | USA | ITA | GBR | FRA | ESP | 0 |
NCT04592653 | Phase Ib/II | ALKS 4230 ALKS 4230 + Pembrolizumab | Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) (ARTISTRY-3) | Recruiting | USA | ESP | 0 |
NCT04677504 | Phase II | Atezolizumab + Cisplatin + Gemcitabine Atezolizumab + Bevacizumab + Cisplatin + Gemcitabine | A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer | Completed | USA | ITA | GBR | ESP | 9 |
NCT04683939 | Phase Ib/II | BNT141 BNT141 + Gemcitabine + Nab-paclitaxel | Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors | Terminated | USA | CAN | 0 |
NCT04727541 | Phase II | Bintrafusp alfa | Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer (NEOBIL) | Terminated | DEU | 0 |
NCT04735796 | Phase I | LM-102 | Study of LM-102 in Subjects in Advanced Tumors | Terminated | USA | 0 |
NCT04779151 | Phase II | Dostarlimab-gxly + Niraparib | Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (NIRADO) | Recruiting | FRA | 0 |
NCT04907851 | Phase II | Denosumab + RXC004 Denosumab + Pembrolizumab + RXC004 | A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (KEYNOTE-E86) | Active, not recruiting | GBR | AUS | 0 |
NCT04941287 | Phase II | Atezolizumab + Varlilumab Atezolizumab + Cobimetinib + Varlilumab | Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of A Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer | Active, not recruiting | USA | 0 |
NCT04969887 | Phase II | Ipilimumab + Nivolumab | Combination Immunotherapy in Rare Cancers Under InvesTigation (MOST-CIRCUIT) | Recruiting | AUS | 1 |
NCT04976634 | Phase II | Belzutifan + Lenvatinib + Pembrolizumab | Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) | Recruiting | USA | FRA | ESP | BEL | AUS | 5 |
NCT05001516 | Phase Ib/II | TPX-4589 | Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors | Active, not recruiting | USA | 0 |
NCT05041972 | Phase II | ARX-788 | ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02) | Withdrawn | USA | 0 |
NCT05052099 | Phase Ib/II | Atezolizumab + Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer (COMBATBIL) | Recruiting | ESP | DEU | 0 |
NCT05074472 | Phase Ib/II | ZB131 | A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors | Active, not recruiting | USA | 0 |
NCT05094336 | Phase Ib/II | AMG193 AMG193 + Docetaxel | AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP) | Recruiting | USA | GBR | FRA | DEU | CAN | BEL | AUT | AUS | 4 |
NCT05239169 | Phase II | Capecitabine + Durvalumab + Tremelimumab Durvalumab + Tremelimumab | Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer | Recruiting | DEU | 0 |
NCT05297903 | Phase II | XmAb20717 | XmAb20717 in Advanced Biliary Tract Cancers | Recruiting | USA | 0 |
NCT05358379 | Phase Ib/II | CYC140 | A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma | Recruiting | USA | ESP | 1 |
NCT05451043 | Phase II | Cisplatin + Durvalumab + Gemcitabine + Propranolol + Tremelimumab Durvalumab + Gemcitabine + Nab-paclitaxel + Propranolol + Tremelimumab Durvalumab + Propranolol + Tremelimumab | Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED) | Not yet recruiting | CAN | 0 |
NCT05482516 | Phase III | Atezolizumab + Bevacizumab | Evaluating Novel Therapies in ctDNA Positive GI Cancers (MRD-GI) | Recruiting | USA | 0 |
NCT05636215 | Phase Ib/II | Orismilast | A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors | Not yet recruiting | AUS | 0 |
NCT05733000 | Phase II | CPI-613 + Gemcitabine + Hydroxychloroquine CPI-613 + Hydroxychloroquine CPI-613 + Gemcitabine CPI-613 + Fluorouracil + Hydroxychloroquine | CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors | Recruiting | USA | 0 |
NCT05771480 | Phase III | Durvalumab + Gemcitabine + Oxaliplatin Cisplatin + Durvalumab + Gemcitabine + Tegafur-gimeracil-oteracil Potassium Durvalumab + Gemcitabine + Tegafur-gimeracil-oteracil Potassium Cisplatin + Durvalumab + Gemcitabine Durvalumab + Gemcitabine Carboplatin + Durvalumab + Gemcitabine Cisplatin + Durvalumab + Gemcitabine + Nab-paclitaxel | Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (TOURMALINE) | Recruiting | USA | ITA | FRA | ESP | DEU | 3 |
NCT05849480 | Phase Ib/II | Capecitabine + CDX-1140 + Oxaliplatin + Pembrolizumab | A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) | Not yet recruiting | USA | 0 |
NCT05875168 | Phase Ib/II | DS-3939a | First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors | Recruiting | USA | 1 |
NCT06001658 | Phase II | Cisplatin + Gemcitabine + Pembrolizumab | Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers | Not yet recruiting | USA | 0 |
NCT06024174 | Phase Ib/II | Adagrasib + BBP-398 + Cetuximab Adagrasib + BBP-398 | A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors | Recruiting | USA | ITA | FRA | ESP | BEL | AUS | 2 |
NCT06048133 | Phase II | AB680 + Cisplatin + Gemcitabine + Zimberelimab | Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers | Not yet recruiting | USA | 0 |
NCT06084481 | Phase I | ABBV-400 | Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 | Recruiting | USA | 0 |
NCT06084689 | Phase II | BI 907828 + Ezabenlimab | Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures (EMPIRE) | Not yet recruiting | FRA | 0 |
NCT06109779 | Phase III | AZD2936 + Cisplatin + Gemcitabine AZD2936 + Tegafur-gimeracil-oteracil Potassium AZD2936 + Capecitabine Capecitabine Tegafur-gimeracil-oteracil Potassium Cisplatin + Gemcitabine | A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Bil01) | Not yet recruiting | GBR | DEU | CAN | AUS | 7 |