Cholangiocarcinoma (bile duct cancer) · line 1 · Durvalumab + gemcitabine + cisplatin (TOPAZ-1) — 1L advanced biliary tract cancer
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Line of therapy | 1 |
|---|---|
| Track | standard |
| Linked regimen | REG-DURVA-GEM-CIS-CHOLANGIO |
| ID | IND-CHOLANGIO-METASTATIC-1L-DURVA-CHEMO |
|---|---|
| Type | Indication |
| Status | reviewed 2026-05-08 | pending_clinical_signoff |
| Diseases | DIS-CHOLANGIOCARCINOMA |
| Sources | SRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY SRC-TOPAZ-1-OH-2022 |
Notes
STUB scaffold — TOPAZ-1 1L IO+chemo for advanced BTC, NCCN category 1 preferred. Auto-generated minimal indication so engine can route end-to-end with new 2024+ standard-of-care; pending Clinical Co-Lead review per CHARTER §6.1 dev-mode signoff exemption. Clinical contraindications (free-text, pending Contraindication-entity authoring): active autoimmune disease requiring systemic immunosuppression (durvalumab); prior solid-organ transplant (rejection risk); ECOG PS ≥ 2 (not enrolled in TOPAZ-1 — gem+cis monotherapy preferred via existing IND-CHOLANGIO-ADVANCED-GEM-CIS); severe renal impairment CrCl <50 mL/min (cisplatin contraindication — carboplatin substitution case-by-case). Required tests (free-text, pending Test-entity authoring): histologic confirmation of BTC; baseline LFTs/CBC/CMP/CrCl; TSH baseline (IO thyroiditis monitoring); CT C/A/P or MRI staging. Desired tests: MSI/MMR (rare MSI-H in BTC, may inform later-line pembro monotherapy); CGP for FGFR2 fusions, IDH1, BRAF, HER2, NTRK (2L+ planning per existing FGFR2-fusion 2L indications); PD-L1 CPS (informational — TOPAZ-1 benefit subgroup-independent). Phasing (induction x 8 → durva maintenance) described in regimen `note...
Used By
Algorithms
ALGO-CHOLANGIO-1L- ALGO-CHOLANGIO-1L
Indication
IND-CHOLANGIO-ADVANCED-GEM-CIS- IND-CHOLANGIO-ADVANCED-GEM-CIS