OpenOnco · CHOLANGIOCARCINOMA · L2 · PEMIGATINIB-CHOLANGIO
← Back to galleryFeedback on this case
Synthetic educational example. Do not self-treat: a qualified treating physician must verify the sources, patient data, contraindications, and final plan.
OpenOnco · Treatment Plan
Treatment plan — Cholangiocarcinoma
PLAN-VERIFIED-CHOLANGIOCARCINOMA-L2-CHOLANGIO_2L_FGFR2_FUSION_PEMI-V1 · v1 · 2026-09-09
Patient
VERIFIED-CHOLANGIOCARCINOMA-L2-CHOLANGIO_2L_FGFR2_FUSION_PEMI · 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
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
ESCAT: clinical review pendingBIO-FGFR2BICC1-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-FGFR2fusion / 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

Aggressive plan
★ DEFAULT
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
Primary current-line option selected by ALGO-CHOLANGIO-2L at step 3; branch-driving red flag: RF-CHOLANGIO-FGFR2-FUSION-ACTIONABLE.

Other current-line alternatives (3 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Aggressive plan
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
Current-line alternative presented for HCP consideration
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
Standard plan
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
Current-line alternative presented for HCP consideration

Why this branch was chosen

Triggers from the patient profile that fired and drove the chosen branch.
Step 3 → branch IND-CHOLANGIO-2L-FGFR2-FUSION-PEMIGATINIB
  • RF-CHOLANGIO-FGFR2-FUSION-ACTIONABLE ★ winner: 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. SRC-NCCN-HEPATOBILIARYSRC-ESMO-BTC-2023SRC-FIGHT-202

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-CBCComplete Blood Count with DifferentialCriticallabaggressive
TEST-CMPComprehensive Metabolic PanelCriticallabaggressive
TEST-CT-CHEST-ABDOMEN-PELVISCT chest + abdomen + pelvis with IV contrastCriticalimagingaggressive
TEST-LFTLiver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)Criticallabaggressive
TEST-ECGElectrocardiogramStandardclinical_assessmentaggressive
TEST-NGS-COMPREHENSIVEComprehensive NGS tumor panel (DNA + RNA, ≥300 genes)DesiredhistologyCSD Lab: M065desired (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.
    Detection: RNA-NGS preferred (captures fusion partners); DNA-NGS with fusion-aware caller acceptable; FISH break-apart secondary. Mandatory pre-treatment NGS in advanced iCCA (NCCN cat 1 testing). Class toxicity: hyperphosphatemia (~50%)…
    RF-CHOLANGIO-FGFR2-FUSION-ACTIONABLESRC-NCCN-HEPATOBILIARYSRC-ESMO-BTC-2023SRC-FIGHT-202
  • IDH1 R132 mutation in intrahepatic cholangiocarcinoma after progression on gemcitabine/cisplatin-based therapy. Routes 2L targeted therapy review toward ivosidenib.
    Мутація IDH1 R132 при внутрішньопечінковій холангіокарциномі після прогресування на терапії на основі гемцитабіну/цисплатину. Спрямовує розгляд таргетної терапії 2L до івосидеnoбу (FIGHT-202: загальна частота відповіді 14.8%, медіана…
    RF-CHOLANGIO-IDH1-R132-ACTIONABLESRC-FIGHT-202SRC-NCCN-HEPATOBILIARYSRC-ESMO-BTC-2023

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-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.
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).

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Pemigatinib monotherapy (FIGHT-202) — 2L+ FGFR2-fusion cholangiocarcinoma
21-day cycles × Until progression / unacceptable toxicity

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

Standard plan

Induction · Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02)
21-day cycles × 6 cycles or until progression / toxicity

MDT brief

Discussion questions (3, 0 blocking)

MDT talk tree (4 steps)

#OwnerTopicAction
1hematologistStaging / disease burden What is the current LDH? Marker of tumor burden and transformation.
2molecular_geneticistBiomarker status 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..
3pathologistBiomarker 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%).
4clinical_pharmacistSpecialist 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

Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.
  • Biomarker coverage: 1/3 known (33%), 2 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
Missing biomarkerLabelMDT ownerDefault trackRequired byNext action
BIO-HER2-SOLIDHER2 status (solid tumors — gastric/GEJ/CRC scoring)pathologistnoIND-CHOLANGIO-2L-HER2-ZANIDATAMABVerify 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%)
BIO-IDH-MUTATIONIDH1 / IDH2 mutation statusmolecular_geneticistnoIND-CHOLANGIO-2L-IDH1-IVOSIDENIBVerify 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.
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).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

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: 2026-09-09.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT05546372Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar CholangiocarcinomaNARECRUITINGAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Single country
NCT07101237An Exploratory Study on Developing an Integrated Approach Combining Multimodal Imaging and Multi-omics Characterization of Tumor Heterogeneity for Precision Diagnosis and Treatment Optimization in Liver Cancer.N/ARECRUITINGPeking Union Medical College HospitalSingle country
NCT06607302Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational StudyN/ARECRUITINGiOMEDICO AGSurrogate endpoint only Single country
NCT07235007Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic CholangiocarcinomaNARECRUITINGAichi Medical University
NCT07726446Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct TumorsPHASE2RECRUITINGTianjin Medical University Cancer Institute and HospitalSmall N (<50) Surrogate endpoint only Single country
NCT04753996Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC PatientsN/ARECRUITINGMayo ClinicSingle country
NCT07301814Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant TumorsN/ARECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologySingle country
NCT06439485Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 FusionPHASE1 / PHASE2RECRUITINGM.D. Anderson Cancer CenterSmall N (<50) Single country
NCT06192797Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic CholangiocarcinomaPHASE2RECRUITINGTongji HospitalSmall N (<50) Single country
NCT07291947PULSAR Combined With Immunotherapy and ChemotherapyPHASE1 / PHASE2RECRUITINGWang XinSingle 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).
OptionUA registrationNSZUCost orientationAccess pathway
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 pathwaynot recorded
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 pathwaynot 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 pathwaynot recorded
Standard plan
Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02) (REG-GEMCITABINE-CISPLATIN-CHOLANGIO)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Trial · NCT05546372
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07101237
An Exploratory Study on Developing an Integrated Approach Combining Multimodal Imaging and Multi-omics Characterization of Tumor Heterogeneity for Precision Diagnosis and Treatment Optimization in Liver Cancer.
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06607302
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07235007
Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07726446
Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04753996
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07301814
Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
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 · NCT06192797
Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07291947
PULSAR Combined With Immunotherapy and Chemotherapy
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: 2026-09-09.