Synthetic educational example. Do not self-treat: a qualified treating physician must verify the sources, patient data, contraindications, and final plan.
Patient
BMA-HER2_AMP_CHOLANGIO · Algorithm: ALGO-CHOLANGIO-1L
Clinical significance of mutations (ESCAT)
Tumor-board context — the engine does not use these tiers to rank tracks
| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|
| ESCAT: clinical review pendingBIO-HER2-SOLID | amplification / overexpression — IHC 3+ or (IHC 2+ + ISH amplified, HER2/CEP17 ≥2.0); ~5-15% of biliary tract cancer (higher in gallbladder + extrahepatic CCA than intrahepatic CCA) | IIA | Standard care - SRC-HERIZON-BTC-01-HARDING-2023: Level B (Supports, Sensitivity/Response)
| HER2-amplified biliary tract cancer (~5-15% overall; enriched in gallbladder + extrahepatic cholangiocarcinoma; ~3-5% intrahepatic CCA): zanidatamab (HER2-targeted biparatopic bispecific antibody) 20 mg/kg IV q2w produced confirmed ORR 41.3% (95% CI 30.4-52.8) in previously treated HER2 IHC 3+ or IHC 2+/ISH+ disease in HERIZON-BTC-01 (Harding et al., Lancet Oncol 2023; n=87). FDA accelerated approval November 2024 for HER2-positive (IHC 3+) BTC ≥2L. ESCAT tier IIA (FDA-approved disease-specific). NCCN category 2A. HER2 testing recommended at diagnosis for unresectable / metastatic BTC per SRC-NCCN-HEPATOBILIARY. Gastric-style scoring (Hofmann 2008 — basolateral / lateral membranous staining ≥10%) is generally applied given basolateral HER2 expression pattern in BTC. | zanidatamab monotherapy 20 mg/kg IV q2w (2L+ post gemcitabine-based 1L per SRC-NCCN-HEPATOBILIARY) | - SRC-HERIZON-BTC-01-HARDING-2023
- SRC-NCCN-HEPATOBILIARY
- SRC-ESMO-BTC-2023
|
Primary current-line option
- Indication
- IND-CHOLANGIO-ADVANCED-GEM-CIS
- Regimen
- Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02)
- Drugs + NSZU
- Gemcitabine (DRUG-GEMCITABINE) Gemcitabine 1000 mg/m² · Per regimen schedule · IV ⚠ NSZU — not for this indication
- Cisplatin (DRUG-CISPLATIN) cisplatin 25 mg/m² IV d1, d8 q3w × 8 cycles · Per regimen schedule · IV ⚠ NSZU — not for this indication
- Reason
- Primary current-line option selected by ALGO-CHOLANGIO-1L at step 3.
Other current-line alternatives (2 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-CHOLANGIO-METASTATIC-1L-DURVA-CHEMO
- Regimen
- Durvalumab + gemcitabine + cisplatin (TOPAZ-1) — 1L advanced biliary tract cancer
- Drugs + NSZU
- Durvalumab (DRUG-DURVALUMAB) 1500 mg IV q3 weeks · Day 1 q3w with chemo (cycles 1-8); then maintenance 1500 mg q4w until progression or unacceptable toxicity · IV ⚠ NSZU — not for this indication
- Gemcitabine (DRUG-GEMCITABINE) 1000 mg/m² IV · Days 1 and 8 of every 21-day cycle, cycles 1-8 · IV ⚠ NSZU — not for this indication
- Cisplatin (DRUG-CISPLATIN) 25 mg/m² IV · Days 1 and 8 of every 21-day cycle, cycles 1-8 · IV ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-CHOLANGIO-METASTATIC-1L-PEMBRO-CHEMO
- Regimen
- Pembrolizumab + gemcitabine + cisplatin (KEYNOTE-966) — 1L advanced biliary tract cancer
- Drugs + NSZU
- Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3 weeks · Day 1 q3w throughout (concurrent with chemo cycles 1-8 then maintenance with gemcitabine until progression / toxicity / 35 cycles total) · IV ⚠ NSZU — not for this indication
- Gemcitabine (DRUG-GEMCITABINE) 1000 mg/m² IV · Days 1 and 8 of every 21-day cycle, continued until progression / toxicity (no fixed cap; cisplatin stops at cycle 8) · IV ⚠ NSZU — not for this indication
- Cisplatin (DRUG-CISPLATIN) 25 mg/m² IV · Days 1 and 8 of every 21-day cycle, cycles 1-8 only (capped at 8 cycles per protocol) · IV ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-CHOLANGIO-METASTATIC-1L-DURVA-CHEMO)
- Не використовуйте за наявності активного аутоімунного захворювання (відносне протипоказання для дурвалумабу — оцінити ризик/користь індивідуально)
- Не продовжуйте дурвалумаб після прогресування — переходьте на 2L (FGFR2/IDH1/BRAF-таргетна терапія за наявності маркерів, або FOLFOX)
- Не використовуйте при ECOG PS ≥ 2 — TOPAZ-1 не включала цих пацієнтів, перевагу має гем+цис монотерапія
- Не пропускайте CGP (FGFR2, IDH1, BRAF, HER2, NTRK) на старті — потрібно для планування 2L
Standard plan (IND-CHOLANGIO-METASTATIC-1L-PEMBRO-CHEMO)
- Не використовуйте за наявності активного аутоімунного захворювання (відносне протипоказання для пембролізумабу — оцінити ризик/користь індивідуально)
- Не продовжуйте пембролізумаб після прогресування — переходьте на 2L
- Не використовуйте при ECOG PS ≥ 2 — KEYNOTE-966 не включала цих пацієнтів
- Не пропускайте CGP (FGFR2, IDH1, BRAF, HER2, NTRK) на старті — потрібно для планування 2L
- Не перевищуйте 35 циклів пембролізумабу (~2 роки) за дизайном KEYNOTE
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Standard plan
Induction · Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02)
21-day cycles × 6 cycles or until progression / toxicity
Standard plan
Induction · Durvalumab + gemcitabine + cisplatin (TOPAZ-1) — 1L advanced biliary tract cancer
21-day cycles × Up to 8 cycles of induction durva + gem + cis (q3w); then durvalumab monotherapy maintenance q4w until progression, unacceptable toxicity, or 24 months total
Standard plan
Induction · Pembrolizumab + gemcitabine + cisplatin (KEYNOTE-966) — 1L advanced biliary tract cancer
21-day cycles × Cisplatin: up to 8 cycles. Gemcitabine + pembrolizumab: continue until progression, unacceptable toxicity, or 35 cycles (~2 years) of pembrolizumab
MDT brief
Data quality
Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.
- Biomarker coverage: 0/0 known (100%), 0 missing, 0 default-track gaps
- Unevaluated RedFlags: RF-CHOLANGIO-FGFR2-FUSION-ACTIONABLE, RF-CHOLANGIO-IDH1-R132-ACTIONABLE, RF-CHOLANGIOCARCINOMA-FRAILTY-AGE, RF-CHOLANGIOCARCINOMA-HIGH-RISK-BIOLOGY, RF-CHOLANGIOCARCINOMA-INFECTION-SCREENING, RF-CHOLANGIOCARCINOMA-ORGAN-DYSFUNCTION, RF-CHOLANGIOCARCINOMA-TRANSFORMATION-PROGRESSION, RF-CLONORCHIS-CHOLANGIO-PREVENTION, RF-OPISTHORCHIS-CHOLANGIO-PREVENTION, RF-PSC-CHOLANGIOCARCINOMA-PREVENTION
Technical MDT skill metadata (0/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
Sources cited
- SRC-ESMO-BTC-2023: Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up (2023)
- SRC-KEYNOTE-966-KELLEY-2023: Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial (2023)
- SRC-NCCN-CNS-2025: NCCN Central Nervous System Cancers (v.3.2025)
- SRC-NCCN-HEPATOBILIARY: NCCN Hepatobiliary Cancers guideline (TODO: confirm year/citation) ()
- SRC-TOPAZ-1-OH-2022: Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer (2022)
Experimental options (clinical trials)
Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-08-03.
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|
| NCT07334119 | Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors | PHASE1 | RECRUITING | — | Biomarker: unclear Phase 1 only Single country | |
| NCT05150691 | A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors | PHASE1 / PHASE2 | RECRUITING | — | Biomarker: enriched Surrogate endpoint only | |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
Option availability in Ukraine
Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|
| Standard plan Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02) (REG-GEMCITABINE-CISPLATIN-CHOLANGIO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Durvalumab + gemcitabine + cisplatin (TOPAZ-1) — 1L advanced biliary tract cancer (REG-DURVA-GEM-CIS-CHOLANGIO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Pembrolizumab + gemcitabine + cisplatin (KEYNOTE-966) — 1L advanced biliary tract cancer (REG-PEMBRO-GEM-CIS-CHOLANGIO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT07334119 Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05150691 A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-08-03.