Biliary tract neoplasm
diseaseOn this page
Also known as biliary tract neoplasm (disease)biliary tree neoplasmbiliary tree neoplasm (disease)biliary tree tumorbiliary tree tumourBILIARY_TRACTneoplasm of biliary treetumor of biliary treetumour of biliary treetumour of the extrahepatic bile duct
Summary
Biliary tract neoplasm (MONDO:0005304) is a cancer and 75 clinical trials. Top therapeutic interventions include cisplatin, tremelimumab, and binimetinib. A subtype of biliary tract disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Classification: Cancer
- Clinical trials: 75
Clinical features
No curated clinical features (Orphanet) for this disease.
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | biliary tract neoplasm |
| Mondo ID | MONDO:0005304 |
| EFO | EFO:0003891 |
| DOID | DOID:0050625 |
| SNOMED CT | 126853008 |
| UMLS | C0005426 |
| MedGen | 14118 |
| Anatomy (UBERON) | UBERON:0001173 |
| Is cancer (heuristic) | yes |
Also known as: biliary tract neoplasm · biliary tract neoplasm (disease) · biliary tree neoplasm · biliary tree neoplasm (disease) · biliary tree tumor · biliary tree tumour · BILIARY_TRACT · neoplasm of biliary tree · tumor of biliary tree · tumour of biliary tree · tumour of the extrahepatic bile duct
Data availability: 1 HPO phenotype.
Disease family
This is a subtype of biliary tract disorder. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by body system or component › digestive system disorder › hepatobiliary disorder › biliary tract disorder › biliary tract neoplasm
Related subtypes (14): bile duct disorder, gallstones, primary biliary cholangitis, bile reflux, postcholecystectomy syndrome, Alagille syndrome, isolated agenesis of gallbladder, cholelithiasis, ketamine-induced biliary dilatation, follicular cholangitis and pancreatitis, idiopathic ductopenia, Caroli syndrome, isolated congenital hepatic fibrosis, Rokitansky-Aschoff sinuses of the gallbladder
Subtypes (2): biliary tract cancer, bile duct neoplasm
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated for this disease
1 approved, 15 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.
| Drug | Development status |
|---|---|
| Zanidatamab | Approved (phase 4) |
| Binimetinib | Phase 3 (in late-stage trials) |
| Capecitabine | Phase 3 (in late-stage trials) |
| Cisplatin | Phase 3 (in late-stage trials) |
| Durvalumab | Phase 3 (in late-stage trials) |
| Encorafenib | Phase 3 (in late-stage trials) |
| Fluorouracil | Phase 3 (in late-stage trials) |
| Futibatinib | Phase 3 (in late-stage trials) |
| Gemcitabine | Phase 3 (in late-stage trials) |
| Ivosidenib | Phase 3 (in late-stage trials) |
| Neratinib | Phase 3 (in late-stage trials) |
| Niraparib | Phase 3 (in late-stage trials) |
| Oxaliplatin | Phase 3 (in late-stage trials) |
| Pembrolizumab | Phase 3 (in late-stage trials) |
| Tegafur | Phase 3 (in late-stage trials) |
| Trastuzumab | Phase 3 (in late-stage trials) |
Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Axitinib, Cediranib, Cetuximab, Envafolimab, Hydroxychloroquine, Ipilimumab, Irinotecan, Lenvatinib, Nivolumab, Panitumumab, Rivoceranib, Sargramostim, Sovatelitide, Tislelizumab, Toripalimab, Trametinib, Tremelimumab.
Clinical trials & evidence
Clinical trials
Clinical trials: 75.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| Not specified | 34 |
| PHASE2 | 27 |
| PHASE4 | 4 |
| PHASE3 | 4 |
| PHASE1/PHASE2 | 3 |
| PHASE1 | 2 |
| PHASE2/PHASE3 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00980889 | PHASE4 | COMPLETED | RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction |
| NCT01315522 | PHASE4 | COMPLETED | Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents |
| NCT01758341 | PHASE4 | COMPLETED | Radiofrequency Ablation for Malignant Biliary Obstruction |
| NCT02943031 | PHASE4 | UNKNOWN | The Effect of Individualized Precision Therapy Programs in Patients With BTC |
| NCT03478488 | PHASE3 | ACTIVE_NOT_RECRUITING | Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC |
| NCT03875235 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) |
| NCT05615818 | PHASE3 | RECRUITING | Personalized Medicine for Advanced Biliary Cancer Patients |
| NCT00939848 | PHASE2/PHASE3 | COMPLETED | Cediranib Versus Placebo Plus Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers |
| NCT01731821 | PHASE3 | COMPLETED | Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy |
| NCT03801083 | PHASE2 | RECRUITING | Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers |
| NCT04308174 | PHASE2 | ACTIVE_NOT_RECRUITING | Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer |
| NCT04579380 | PHASE2 | ACTIVE_NOT_RECRUITING | Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations |
| NCT04910386 | PHASE2 | NOT_YET_RECRUITING | Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers |
| NCT04956640 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) |
| NCT06037655 | PHASE2 | NOT_YET_RECRUITING | Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC |
| NCT06638931 | PHASE2 | RECRUITING | Agnostic Therapy in Rare Solid Tumors |
| NCT07109167 | PHASE2 | NOT_YET_RECRUITING | The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors |
| NCT07146646 | PHASE2 | RECRUITING | Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer |
| NCT07160283 | PHASE2 | NOT_YET_RECRUITING | The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer |
| NCT07269158 | PHASE1/PHASE2 | NOT_YET_RECRUITING | A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer |
| NCT00174564 | PHASE2 | COMPLETED | EXIBIT: Oxaliplatin in Biliary Tract Cancer |
| NCT00268840 | PHASE2 | COMPLETED | The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer |
| NCT00487851 | PHASE2 | WITHDRAWN | Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer |
| NCT01853618 | PHASE1/PHASE2 | COMPLETED | Tremelimumab With Chemoembolization or Ablation for Liver Cancer |
| NCT02146703 | PHASE2 | COMPLETED | Gemcitabine and S-1 for Advanced Biliary Tract Cancer |
| NCT02527824 | PHASE2 | UNKNOWN | Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer |
| NCT02558959 | PHASE2 | COMPLETED | Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer |
| NCT02821754 | PHASE2 | COMPLETED | A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) |
| NCT02829918 | PHASE2 | COMPLETED | Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers |
| NCT03046862 | PHASE2 | UNKNOWN | Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer |
| NCT03101566 | PHASE2 | COMPLETED | Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer |
| NCT03111732 | PHASE2 | COMPLETED | Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC) |
| NCT03406299 | PHASE2 | COMPLETED | Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer |
| NCT03427242 | PHASE2 | UNKNOWN | Apatinib for Advanced Biliary Carcinoma |
| NCT04010071 | PHASE2 | UNKNOWN | Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors |
| NCT04352023 | PHASE2 | UNKNOWN | Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural |
| NCT04566133 | PHASE2 | TERMINATED | Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). |
| NCT05190575 | PHASE2 | COMPLETED | TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer |
| NCT05935579 | PHASE2 | UNKNOWN | Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer |
| NCT07614061 | PHASE1 | RECRUITING | Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| CISPLATIN | 4 | 8 |
| TREMELIMUMAB | 4 | 3 |
| BINIMETINIB | 4 | 1 |
| CHLOROTRIANISENE | 4 | 1 |
| DURVALUMAB | 4 | 1 |
| ENCORAFENIB | 4 | 1 |
| FUTIBATINIB | 4 | 1 |
| GEMCITABINE | 4 | 1 |
| IVOSIDENIB | 4 | 1 |
| NERATINIB | 4 | 1 |
| NIRAPARIB | 4 | 1 |
| SELUMETINIB | 4 | 1 |
| TEGAFUR | 4 | 1 |
| TIPIRACIL | 4 | 1 |
| TRIFLURIDINE | 4 | 1 |
| TUCATINIB | 4 | 1 |
| ZANIDATAMAB | 4 | 1 |
| CEDIRANIB | 3 | 1 |
| OLOMORASIB | 3 | 1 |
| OSEMITAMAB | 2 | 1 |
| CHEMBL235993 | 0 | 1 |
| CHEMBL5433950 | 0 | 1 |
| CHEMBL5723337 | 0 | 1 |
| CHEMBL4463209 | 0 | 1 |