OpenOnco · Treatment Plan

Treatment plan — Cholangiocarcinoma

PLAN-BMA-FGFR2_BICC1_CHOLANGIO-V1 · v1 · 2026-08-03

Patient

BMA-FGFR2_BICC1_CHOLANGIO · Algorithm: ALGO-CHOLANGIO-1L

DiagnosisCholangiocarcinoma

MOH / ICD-10C22.1, C24.0

ICD-O-38160/3; C22.1, C24.0, C24.8

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-FGFR2	BICC1-FGFR2 fusion (most common partner ~30-40% of FGFR2-fusion cholangio)	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Positive) Trial or research option SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	BICC1-FGFR2 fusion is the most common FGFR2 fusion partner in intrahepatic cholangiocarcinoma. Treatment is identical to gene-level FGFR2-fusion: pemigatinib (FIGHT-202) and futibatinib (FOENIX-CCA2). Fusion-partner identity does not currently modify TKI selection.	pemigatinib monotherapy futibatinib monotherapy	SRC-FDA-CDS-2026
ESCAT: clinical review pendingBIO-FGFR2	fusion / rearrangement (BICC1-FGFR2 most common; ~10-15% intrahepatic cholangio)	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Positive) Trial or research option SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	FGFR2 fusion in intrahepatic cholangiocarcinoma (~10-15%): pemigatinib (FIGHT-202, Abou-Alfa Lancet Oncol 2020 — ORR 36%, mDOR 9.1 mo) and futibatinib (FOENIX-CCA2, Goyal NEJM 2023 — ORR 42%, mPFS 9.0 mo) are FDA-approved for previously-treated FGFR2-fusion cholangio. Futibatinib is irreversible and has activity against pemigatinib-resistance gatekeeper mutations.	pemigatinib monotherapy (2L+ post-gemcitabine/cisplatin) futibatinib monotherapy (2L+; preferred after pemigatinib resistance)	SRC-FDA-CDS-2026

Primary current-line option

Standard plan

★ DEFAULT

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.

Standard plan

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

Standard plan

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	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	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
NCT06439485	Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion	PHASE1 / PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Biomarker: enriched Small N (<50) Single country
NCT06728410	A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement	PHASE2	RECRUITING	Mehmet Akce	—	Small N (<50) Surrogate endpoint only Single country
NCT04353375	HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma	PHASE2 / PHASE3	RECRUITING	Hutchmed	—	Biomarker: enriched Surrogate endpoint only Single country
NCT07359820	A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement	PHASE2	RECRUITING	Elevar Therapeutics	—	Biomarker: enriched Small N (<50) Surrogate endpoint only
NCT05678270	A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma	PHASE2	RECRUITING	Beijing InnoCare Pharma Tech Co., Ltd.	—	Biomarker: enriched Surrogate endpoint only Single country
NCT05727176	Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement	PHASE2	RECRUITING	Taiho Oncology, Inc.	—	Biomarker: enriched Surrogate endpoint only
NCT06160752	Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations	PHASE1	RECRUITING	Tyra Biosciences, Inc	—	Phase 1 only Small N (<50) Single country

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 · NCT06439485 Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06728410 A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04353375 HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07359820 A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05678270 A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05727176 Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06160752 Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations 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.

plan_id: PLAN-BMA-FGFR2_BICC1_CHOLANGIO-V1 | version: 1 | generated: 2026-08-03T12:01:52.647129+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.