Cholangiocarcinoma (bile duct cancer) · line 2 · Zanidatamab — 2L+ HER2-amplified biliary tract cancer (HERIZON-BTC-01)
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 | 2 |
|---|---|
| Track | aggressive |
| Linked regimen | REG-ZANIDATAMAB |
| ID | IND-CHOLANGIO-2L-HER2-ZANIDATAMAB |
|---|---|
| Type | Indication |
| Status | reviewed 2026-05-08 | pending_clinical_signoff |
| Diseases | DIS-CHOLANGIOCARCINOMA |
| Sources | SRC-ESMO-BTC-2023 SRC-HERIZON-BTC-01-HARDING-2023 SRC-NCCN-HEPATOBILIARY |
Notes
STUB — pending Clinical Co-Lead sign-off. Aggressive-track 2L+ for HER2-amplified BTC. NCCN cat 2A; FDA accelerated approval Nov 2024. ESCAT tier IIA (FDA-approved disease-specific). HER2 amplification ~5-15% of BTC overall (higher in gallbladder + extrahepatic CCA). HERIZON-BTC-01 cohort 1 (n=87, IHC 3+ or IHC 2+/ISH+): confirmed ORR 41.3%, mPFS 5.5 mo, mOS 15.5 mo, DoR 14.9 mo. Confirmatory phase 3 pending; traditional approval pending. UA access: named-patient / EAP only.
Used By
Algorithms
ALGO-CHOLANGIO-2L- ALGO-CHOLANGIO-2L