OpenOnco · Treatment Plan

Treatment plan — Cholangiocarcinoma

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

Patient

VAR-CHOLANGIOCARCINOMA-RELAPSED · Algorithm: ALGO-CHOLANGIO-2L

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

Aggressive plan

★ DEFAULT

Indication

IND-CHOLANGIO-2L-IDH1-IVOSIDENIB

Regimen

Ivosidenib monotherapy (ClarIDHy) — 2L+ IDH1-mutated cholangiocarcinoma

Drugs + NSZU

Ivosidenib (DRUG-IVOSIDENIB) 500 mg PO once daily, continuous · PO daily, 28-day cycle (continuous; no scheduled break) · PO ✗ Not registered in UA

Reason

Primary current-line option selected by ALGO-CHOLANGIO-2L at step 4.

Other current-line alternatives (2 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Aggressive plan

Indication

IND-CHOLANGIO-2L-HER2-ZANIDATAMAB

Regimen

Zanidatamab — 2L+ HER2-amplified biliary tract cancer (HERIZON-BTC-01)

Drugs + NSZU

Zanidatamab (DRUG-ZANIDATAMAB) 20 mg/kg · IV q2 weeks until progression / unacceptable toxicity · IV ✗ Not registered in UA

Reason

Current-line alternative presented for HCP consideration

Aggressive plan

Indication

IND-CHOLANGIO-2L-FGFR2-FUSION-PEMIGATINIB

Regimen

Pemigatinib monotherapy (FIGHT-202) — 2L+ FGFR2-fusion cholangiocarcinoma

Drugs + NSZU

Pemigatinib (DRUG-PEMIGATINIB) 13.5 mg PO once daily, 14 days on / 7 days off · PO daily, 21-day cycle (14 on / 7 off) · PO ✗ Not registered in UA

Reason

Current-line alternative presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

ID	Name	Priority	Category	Where to order	Needed for
TEST-CBC	Complete Blood Count with Differential	Critical	lab	—	all tracks
TEST-CMP	Comprehensive Metabolic Panel	Critical	lab	—	all tracks
TEST-CT-CHEST-ABDOMEN-PELVIS	CT chest + abdomen + pelvis with IV contrast	Critical	imaging	—	all tracks
TEST-LFT	Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)	Critical	lab	—	all tracks
TEST-ECG	Electrocardiogram	Standard	clinical_assessment	—	all tracks
TEST-NGS-COMPREHENSIVE	Comprehensive NGS tumor panel (DNA + RNA, ≥300 genes)	Desired	histology	CSD Lab: M065	desired (aggressive)

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

FGFR2 fusion or rearrangement in advanced/metastatic intrahepatic cholangiocarcinoma (~10–20% of iCCA; rare in extrahepatic / gallbladder). Treatment-defining for 2L+: pemigatinib (FIGHT-202 ORR 35.5%, mPFS 6.9 mo, mOS 21.1 mo; FDA Apr 2020) preferred when FGFR2 fusion confirmed; futibatinib (FOENIX-CCA2) covalent FGFR-TKI alternative, including some pemigatinib-resistance variants. Common partners: BICC1-FGFR2, FGFR2-AHCYL1, FGFR2-CCDC6. RF-CHOLANGIO-FGFR2-FUSION-ACTIONABLE
IDH1 R132 mutation in intrahepatic cholangiocarcinoma after progression on gemcitabine/cisplatin-based therapy. Routes 2L targeted therapy review toward ivosidenib. RF-CHOLANGIO-IDH1-R132-ACTIONABLE

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity

Aggressive plan (IND-CHOLANGIO-2L-IDH1-IVOSIDENIB)

Do NOT prescribe without confirmed IDH1 R132 mutation testing (tumor NGS or ctDNA) — amplification, IDH2 mutation, or non-R132 IDH1 mutations are NOT eligible.
Do NOT start without baseline ECG and correction of electrolytes (K, Mg, Ca) — QT prolongation is a class adverse effect.
Do NOT combine with strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John's wort) — ivosidenib exposure is sharply reduced.
Do NOT skip QTc monitoring (ECG at week 1, 2, 4, then monthly or as clinically indicated).
Do NOT rely on hormonal contraception as the sole method — ivosidenib induces CYP3A4; barrier contraception is required.
Do NOT confirm the plan without funding pathway — ivosidenib not registered in UA.

Aggressive plan (IND-CHOLANGIO-2L-HER2-ZANIDATAMAB)

Do NOT prescribe without confirmed HER2-amplification (IHC 3+ or IHC 2+/ISH+) — lower-level protein expression alone is insufficient for this indication.
Do NOT start without baseline echocardiogram / MUGA — HER2-targeted class toxicity includes LVEF decline.
Do NOT skip premedication for first 2-3 infusions — infusion reactions ~33%.
Do NOT ignore diarrhea prophylaxis — ~40% any-grade; patient must have loperamide at home with clear escalation plan.
Do NOT confirm the plan without funding pathway — zanidatamab not registered in UA (named-patient / EAP only).

Aggressive plan (IND-CHOLANGIO-2L-FGFR2-FUSION-PEMIGATINIB)

Do NOT prescribe without RNA-NGS (or DNA-NGS fusion-aware / FISH break-apart) confirmation of FGFR2 fusion — amplification alone is insufficient for this indication.
Do NOT start without baseline ophthalmologic exam — serous retinopathy / RPE detachment — class toxicity.
Do NOT ignore phosphate monitoring — hyperphosphatemia requires diet + sevelamer; delay / dose reduction at >7 mg/dL.
Do NOT combine with strong CYP3A4 inducers — pemigatinib exposure is sharply reduced.
Do NOT confirm the plan without funding pathway — pemigatinib not registered in UA.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Ivosidenib monotherapy (ClarIDHy) — 2L+ IDH1-mutated cholangiocarcinoma

28-day cycles × Until progression / unacceptable toxicity

Aggressive plan

Induction · Zanidatamab — 2L+ HER2-amplified biliary tract cancer (HERIZON-BTC-01)

14-day cycles × Until progression or unacceptable toxicity

Aggressive plan

Induction · Pemigatinib monotherapy (FIGHT-202) — 2L+ FGFR2-fusion cholangiocarcinoma

21-day cycles × Until progression / unacceptable toxicity

MDT brief

Discussion questions (3, 1 blocking)

OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist
BLOCKING OQ-BIOMARKER-IDH-MUTATION
What is the status of IDH1 / IDH2 mutation status (BIO-IDH-MUTATION)? It is required by track(s): IND-CHOLANGIO-2L-IDH1-IVOSIDENIB. Expected value: IDH1 R132 hotspot mutation positive (R132C / R132L / R132G / R132H / R132S; tumor NGS preferred; ctDNA acceptable when tumor tissue insufficient). IDH2 mutations NOT eligible..
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist
OQ-BIOMARKER-HER2-SOLID
What is the status of HER2 status (solid tumors — gastric/GEJ/CRC scoring) (BIO-HER2-SOLID)? It is required by track(s): IND-CHOLANGIO-2L-HER2-ZANIDATAMAB. Expected value: HER2 IHC 3+ OR (IHC 2+ AND ISH amplified, HER2/CEP17 ratio ≥2.0); gastric-style scoring (Hofmann 2008 — basolateral/lateral membranous staining ≥10%).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ pathologist

MDT talk tree (4 steps)

#	Owner	Topic	Action
1	molecular_geneticist	Biomarker status BLOCKING	What is the status of IDH1 / IDH2 mutation status (BIO-IDH-MUTATION)? It is required by track(s): IND-CHOLANGIO-2L-IDH1-IVOSIDENIB. Expected value: IDH1 R132 hotspot mutation positive (R132C / R132L / R132G / R132H / R132S; tumor NGS preferred; ctDNA acceptable when tumor tissue insufficient). IDH2 mutations NOT eligible..
2	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
3	pathologist	Biomarker status	What is the status of HER2 status (solid tumors — gastric/GEJ/CRC scoring) (BIO-HER2-SOLID)? It is required by track(s): IND-CHOLANGIO-2L-HER2-ZANIDATAMAB. Expected value: HER2 IHC 3+ OR (IHC 2+ AND ISH amplified, HER2/CEP17 ratio ≥2.0); gastric-style scoring (Hofmann 2008 — basolateral/lateral membranous staining ≥10%).
4	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
Owns: OQ-BIOMARKER-IDH-MUTATION

Data quality

Incomplete for default-track review. Default-track review is incomplete until required biomarker gaps are resolved.

Biomarker coverage: 1/3 known (33%), 2 missing, 1 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

Missing biomarker	Label	MDT owner	Default track	Required by	Next action
`BIO-IDH-MUTATION`	IDH1 / IDH2 mutation status	molecular_geneticist	yes	IND-CHOLANGIO-2L-IDH1-IVOSIDENIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: IDH1 R132 hotspot mutation positive (R132C / R132L / R132G / R132H / R132S; tumor NGS preferred; ctDNA acceptable when tumor tissue insufficient). IDH2 mutations NOT eligible.
`BIO-HER2-SOLID`	HER2 status (solid tumors — gastric/GEJ/CRC scoring)	pathologist	no	IND-CHOLANGIO-2L-HER2-ZANIDATAMAB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: HER2 IHC 3+ OR (IHC 2+ AND ISH amplified, HER2/CEP17 ratio ≥2.0); gastric-style scoring (Hofmann 2008 — basolateral/lateral membranous staining ≥10%)

Technical MDT skill metadata (2/16 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-CLARIDHY-ABOU-ALFA-2020: Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study (2020)
SRC-ESMO-BTC-2023: Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up (2023)
SRC-FIGHT-202: FIGHT-202 — pemigatinib in FGFR2-fusion cholangiocarcinoma (TODO: confirm citation) ()
SRC-HERIZON-BTC-01-HARDING-2023: Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study (2023)
SRC-NCCN-HEPATOBILIARY: NCCN Hepatobiliary Cancers guideline (TODO: confirm year/citation) ()

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
Aggressive plan Ivosidenib monotherapy (ClarIDHy) — 2L+ IDH1-mutated cholangiocarcinoma (REG-IVOSIDENIB-CHOLANGIO) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Zanidatamab — 2L+ HER2-amplified biliary tract cancer (HERIZON-BTC-01) (REG-ZANIDATAMAB) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Pemigatinib monotherapy (FIGHT-202) — 2L+ FGFR2-fusion cholangiocarcinoma (REG-PEMIGATINIB-CHOLANGIO) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
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-RELAPSED-V1 | version: 1 | generated: 2026-05-13T10:01:51.829562+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.