| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| ESCAT: clinical review pendingBIO-PDGFRA | D842V (activation loop, exon 18 — ~7% of GIST, predominantly gastric) | IA | Molecular evidence option
Resistance or avoidance signal Trial or research option
| PDGFRA D842V in GIST is imatinib-RESISTANT (distinct from imatinib-sensitive PDGFRA non-D842V mutations). Avapritinib (NAVIGATOR phase 1/2 + VOYAGER phase 3, Heinrich Lancet Oncol 2020 / Kang JCO 2022 — ORR 88-91% in D842V GIST; treatment-naive cohort) is FDA-approved for advanced D842V GIST. Imatinib, sunitinib, regorafenib are ineffective. | avapritinib monotherapy (1L for advanced D842V GIST — irrespective of line) |
|
| ESCAT: clinical review pendingBIO-PDGFRA | exon 12 mutation (juxtamembrane domain — V561D most common; rare <2% GIST) | IB | Molecular evidence option
Resistance or avoidance signal | PDGFRA exon 12 mutations in GIST are imatinib-sensitive. Imatinib 400 mg/day is standard 1L — response rates comparable to KIT exon 11 and PDGFRA non-D842V exon 18. Rare genotype (<2% of GIST). | imatinib 400 mg/day (1L advanced/metastatic) |
|
| ESCAT: clinical review pendingBIO-PDGFRA | exon 14 mutation (ATP-binding pocket — N659K, N659Y; very rare) | IB | Molecular evidence option
Resistance or avoidance signal | PDGFRA exon 14 mutations in GIST are very rare and are imatinib- sensitive. Treatment is identical to other imatinib-sensitive PDGFRA variants: imatinib 400 mg/day 1L. Per OncoKB and NCCN, all PDGFRA non-D842V mutations are grouped as imatinib-responsive. | imatinib 400 mg/day (1L advanced/metastatic) |
|
| ESCAT: clinical review pendingBIO-PDGFRA | exon 18 non-D842V mutation (e.g., D846Y, N848K, Y849K, deletion DIM842-844) | IB | Molecular evidence option
Resistance or avoidance signal Trial or research option
| PDGFRA non-D842V exon 18 mutations in GIST are imatinib-SENSITIVE (distinct from D842V). Imatinib 400 mg/day is standard 1L — responses comparable to KIT exon 11 GIST. Avapritinib also active. Genotyping is mandatory to distinguish D842V (avapritinib) from non-D842V exon 18 (imatinib-first). | imatinib 400 mg/day (1L advanced/metastatic non-D842V exon 18 PDGFRA) avapritinib (alternative; investigational) |
|
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | molecular_geneticist | Biomarker status BLOCKING | What is the status of KIT mutation (BIO-KIT)? It is required by track(s): IND-GIST-1L-IMATINIB. Expected value: exon 11 OR exon 9 mutation positive. |
| 2 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 3 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|---|---|---|---|---|
BIO-KIT | KIT mutation | molecular_geneticist | yes | IND-GIST-1L-IMATINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: exon 11 OR exon 9 mutation positive |
| 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) |
|---|---|---|---|---|---|---|---|
| NCT06630234 | A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST) | PHASE1 / PHASE2 | RECRUITING | Deciphera Pharmaceuticals, LLC | — | Biomarker: enriched 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 | |
| NCT05461664 | Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA | N/A | RECRUITING | Xinhua Zhang, MD | — | Surrogate endpoint only 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 · NCT06630234 A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (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 · NCT05461664 Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA 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: 2026-08-03.