OpenOnco · Treatment Plan

Treatment plan — Cholangiocarcinoma

PLAN-AUTO-CHOLANGIOCARCINOMA-001-V1 · v1 · 2026-07-26

Patient

AUTO-CHOLANGIOCARCINOMA-001 · 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
No clinically actionable variants matched in this profile.

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: 2026-07-26.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06720883	Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study	N/A	RECRUITING	Azienda Ospedaliera di Padova	—	Small N (<50) Single country
NCT06199895	Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer	PHASE2	RECRUITING	Liu Huang	—	Small N (<50) Surrogate endpoint only Single country
NCT06302621	Pemigatinib + Afatinib in Advanced Refractory Solid Tumors	PHASE1	RECRUITING	Massachusetts General Hospital	—	Phase 1 only Surrogate endpoint only Single country
NCT05223816	An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma	PHASE2	RECRUITING	Virogin Biotech Canada Ltd	—	Surrogate endpoint only Single country
NCT07155525	Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas	PHASE3	RECRUITING	Minia University	—	Single country
NCT06298968	Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma	PHASE2	RECRUITING	Nanfang Hospital, Southern Medical University	—	Small N (<50) Surrogate endpoint only Single country
NCT05727176	Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement	PHASE2	RECRUITING	Taiho Oncology, Inc.	—	Surrogate endpoint only
NCT06441747	Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP)	PHASE2	RECRUITING	Australasian Gastro-Intestinal Trials Group	—	Small N (<50) Single country
NCT06718257	Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma	N/A	RECRUITING	Second Affiliated Hospital, School of Medicine, Zhejiang University	—	Single country
NCT07632235	A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma	PHASE1 / PHASE2	RECRUITING	Shanghai 6th People's Hospital	—	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 · NCT06720883 Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06199895 Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06302621 Pemigatinib + Afatinib in Advanced Refractory Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05223816 An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07155525 Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06298968 Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable 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 · NCT06441747 Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06718257 Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07632235 A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic 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: 2026-07-26.

plan_id: PLAN-AUTO-CHOLANGIOCARCINOMA-001-V1 | version: 1 | generated: 2026-07-26T09:28:48.387476+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.