OpenOnco · Treatment Plan

Treatment plan — Cholangiocarcinoma

PLAN-VAR-CHOLANGIOCARCINOMA-HBV-V1 · v1 · 2026-05-13

Patient

VAR-CHOLANGIOCARCINOMA-HBV · 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

✅ Covered biomarkers (matched in KB)

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

⚠️ Not included in plan

Biomarker	Status
BIO-FGFR2	BIO definition in KB; no ESCAT BMA entry — verify with clinician

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

MDT talk tree (1 steps)

#	Owner	Topic	Action
1	infectious_disease_hepatology	Specialist review	Active viral etiology (HCV/HBV) requires parallel antiviral management and reactivation risk assessment.

Skills (recommended) — for consideration (1)

Infectious disease / hepatology recommended
Active viral etiology (HCV/HBV) requires parallel antiviral management and reactivation risk assessment.

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

Technical MDT skill metadata (1/16 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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06037980	CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence	PHASE2 / PHASE3	RECRUITING	Gruppo Oncologico del Nord-Ovest	—	Surrogate endpoint only Single country
NCT06546969	Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer	PHASE1	RECRUITING	University of Maryland, Baltimore	—	Phase 1 only Small N (<50) Single country
NCT04037007	Efficacy of Fistulotomy for Biliary Cannulation	NA	RECRUITING	Coordinación de Investigación en Salud, Mexico	—	Single country
NCT06888063	Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery	PHASE2	RECRUITING	Erasmus Medical Center	—	Small N (<50) Single country
NCT06914648	The Dragon PLC Trial (DRAGON-PLC)	NA	RECRUITING	Maastricht University	—	—
NCT07224464	The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.	NA	RECRUITING	New Phase Ltd.	—	Small N (<50) Single country
NCT03445585	Biobank for Cholestatic Liver Diseases.	N/A	RECRUITING	Mayo Clinic	—	Single country
NCT04378023	Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.	N/A	RECRUITING	Hospital Vall d'Hebron	—	Small N (<50) Single country
NCT06774690	Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study	N/A	RECRUITING	IRCCS Azienda Ospedaliero-Universitaria di Bologna	—	Single country
NCT06746480	Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma	PHASE2	RECRUITING	CNBG-Virogin Biotech (Shanghai) Ltd.	—	Small N (<50) Surrogate endpoint only 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 · NCT06037980 CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06546969 Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04037007 Efficacy of Fistulotomy for Biliary Cannulation No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06888063 Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06914648 The Dragon PLC Trial (DRAGON-PLC) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07224464 The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03445585 Biobank for Cholestatic Liver Diseases. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04378023 Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06774690 Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06746480 Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma 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: 2026-05-13.

plan_id: PLAN-VAR-CHOLANGIOCARCINOMA-HBV-V1 | version: 1 | generated: 2026-05-13T10:01:51.816913+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.