| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| ESCAT: clinical review pendingBIO-KIT | exon 11 deletion / insertion (juxtamembrane domain — ~50% of GIST) | IA | Resistance or avoidance signal | KIT exon 11 mutation in GIST: imatinib 400 mg/day is standard 1L (B2222, Demetri NEJM 2002 — ORR 67%; EORTC-62005 / S0033 confirmed long-term benefit). Exon 11 mutants have the longest PFS and OS on imatinib of any GIST genotype. Adjuvant imatinib 3 yr post- resection improves RFS in high-risk disease (SSG-XVIII / ACOSOG-Z9001). | imatinib 400 mg/day (1L advanced/metastatic) imatinib 400 mg/day adjuvant 3 yr (high-risk resected: ≥3 cm + mitoses ≥5/50 HPF, or rupture, or non-gastric primary) imatinib adjuvant 6 yr (extended for highest-risk per PERSIST-5 / SSG-XXII) |
|
| Biomarker | Status |
|---|---|
| PDGFRA | Excluded (negative) |
| SDH | Not in KB — ask clinician to verify |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 3 | molecular_geneticist | Specialist review | Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed. |
| 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) |
|---|---|---|---|---|---|---|---|
| NCT04181970 | Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK | N/A | RECRUITING | Grupo Espanol de Investigacion en Sarcomas | — | — | |
| NCT06380816 | A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer | PHASE1 / PHASE2 | RECRUITING | Cancer Research UK | — | Single country | |
| NCT07406633 | KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line) | PHASE2 | RECRUITING | Kumquat Biosciences Inc. | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07171203 | Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor | PHASE1 | RECRUITING | University of California, San Diego | — | Phase 1 only Small N (<50) Single country | |
| NCT07559864 | Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment | PHASE2 | RECRUITING | Jian Li | — | Surrogate endpoint only Single country | |
| NCT05751733 | Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST | NA | RECRUITING | Xiangya Hospital of Central South University | — | Surrogate endpoint only Single country | |
| NCT04557969 | Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis | N/A | RECRUITING | National Cancer Institute (NCI) | — | Surrogate endpoint only Single country | |
| NCT05385549 | 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk | PHASE2 | RECRUITING | Asan Medical Center | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT05464875 | A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors | N/A | RECRUITING | Xinhua Zhang, MD | — | Surrogate endpoint only Single country | |
| NCT07673861 | Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients | NA | RECRUITING | Royal Marsden NHS Foundation Trust | — | 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 |
|---|---|---|---|---|
| Standard plan Imatinib (GIST advanced/metastatic 1L; KIT/PDGFRA imatinib-sensitive) (REG-IMATINIB-GIST-1L) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Avapritinib monotherapy (GIST advanced/metastatic 1L; PDGFRA D842V) (REG-AVAPRITINIB-GIST-1L) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Trial · NCT04181970 Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06380816 A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07406633 KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07171203 Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07559864 Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05751733 Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04557969 Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05385549 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05464875 A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07673861 Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients 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: 2026-08-17.