| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| ESCAT: clinical review pendingBIO-IDH-MUTATION | IDH1 R132 hotspot (R132C ~70%, R132L, R132G, R132H, R132S; ~13-20% of intrahepatic cholangiocarcinoma) | IA | Resistance or avoidance signal
| IDH1 R132 hotspot mutations occur in ~13-20% of intrahepatic cholangiocarcinoma and are FDA Level-1 actionable. Ivosidenib was FDA-approved 2021 for previously-treated IDH1-mutated locally advanced/metastatic cholangiocarcinoma based on ClarIDHy (Abou-Alfa Lancet Oncol 2020 — mPFS 2.7 vs 1.4 mo, HR 0.37; OS benefit on rank-preserving structural failure time analysis adjusted for crossover) per SRC-NCCN-HEPATOBILIARY. Comprehensive molecular profiling at diagnosis is recommended to identify IDH1-R132 patients who can be sequenced to ivosidenib in 2L after gemcitabine/cisplatin ± durvalumab (TOPAZ-1) 1L. | ivosidenib monotherapy (2L+ IDH1 R132-mutated cholangio per SRC-NCCN-HEPATOBILIARY) |
|
| Biomarker | Status |
|---|---|
| IDH1 | Not in KB — ask clinician to verify |
| FGFR2 | Excluded (negative) |
| MSI | Not in KB — ask clinician to verify |
IND-CHOLANGIO-2L-IDH1-IVOSIDENIB| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | aggressive |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | aggressive |
| TEST-CT-CHEST-ABDOMEN-PELVIS | CT chest + abdomen + pelvis with IV contrast | Critical | imaging | — | aggressive |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | aggressive |
| TEST-ECG | Electrocardiogram | Standard | clinical_assessment | — | aggressive |
| TEST-NGS-COMPREHENSIVE | Comprehensive NGS tumor panel (DNA + RNA, ≥300 genes) | Desired | histology | CSD Lab: M065 | desired (aggressive) |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | 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%). |
| 3 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 4 | molecular_geneticist | Specialist review | Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed. |
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|---|---|---|---|---|
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%) |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|---|---|---|---|---|---|---|
| NCT03364530 | Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma | PHASE2 | RECRUITING | University Hospital, Montpellier | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07282912 | Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels | PHASE2 | RECRUITING | Yale University | — | Surrogate endpoint only Single country | |
| NCT07020221 | A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors | PHASE1 / PHASE2 | RECRUITING | Verastem, Inc. | — | — | |
| NCT07301814 | Clinical Application of PET Imaging Targeting CLDN18.2 in Malignant Tumors | N/A | RECRUITING | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | — | Single country | |
| NCT07161869 | Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III) | N/A | RECRUITING | Erasmus Medical Center | — | Single country | |
| NCT06375915 | Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy | PHASE2 | RECRUITING | Francesco De Cobelli | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07398339 | Cosiporfin Sodium for Injection Photodynamic Therapy | PHASE2 | RECRUITING | Shanghai Guangsheng Biopharmaceutical Co., Ltd | — | Small N (<50) Single country | |
| NCT06487663 | TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors | NA | RECRUITING | Tianjin Medical University Cancer Institute and Hospital | — | Small N (<50) Single country | |
| NCT06140134 | Liver Transplantation in Intrahepatic Cholangiocarcinoma | N/A | RECRUITING | Rutgers, The State University of New Jersey | — | Small N (<50) Single country | |
| NCT06341764 | Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma | PHASE2 | RECRUITING | National Cancer Institute, Naples | — | Small N (<50) Single country |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| 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 |
| Standard plan Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02) (REG-GEMCITABINE-CISPLATIN-CHOLANGIO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT03364530 Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07282912 Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07020221 A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors 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 · NCT07161869 Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06375915 Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07398339 Cosiporfin Sodium for Injection Photodynamic Therapy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06487663 TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06140134 Liver Transplantation in Intrahepatic Cholangiocarcinoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06341764 Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced 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. Table assembled: 2026-10-18. Table assembly does not verify registration, NSZU coverage or prices. Check the currency of these data separately.