OpenOnco · GIST - KIT exon 11 - genotype sets TKI dose
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OpenOnco · Treatment Plan
Treatment plan — Gastrointestinal stromal tumor
PLAN-SHOWCASE-GIST-KIT11-001-V1 · v1 · 2026-08-17
Patient
SHOWCASE-GIST-KIT11-001 · Algorithm: ALGO-GIST-1L
DiagnosisGastrointestinal stromal tumor
MOH / ICD-10C49
ICD-O-38936/3; C15, C16, C17, C18, C19, C20, C26
StageIV

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
✅ Covered biomarkers (matched in KB)
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
ESCAT: clinical review pendingBIO-KITexon 11 deletion / insertion (juxtamembrane domain — ~50% of GIST)IA
Molecular evidence option
  • SRC-CIVIC: Level A (Supports, Sensitivity/Response)
  • SRC-CIVIC: Level B (Supports, Poor Outcome)
Resistance or avoidance signal
Trial or research option
  • SRC-CIVIC: Level C (Supports, Reduced Sensitivity)
  • SRC-CIVIC: Level D (Supports, Sensitivity/Response)
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)
  • SRC-IRIS-OBRIEN-2003
  • SRC-NCCN-MELANOMA-2025
⚠️ Not included in plan
BiomarkerStatus
PDGFRAExcluded (negative)
SDHNot in KB — ask clinician to verify

Primary current-line option

Standard plan
★ DEFAULT
Indication
IND-GIST-1L-IMATINIB
Regimen
Imatinib (GIST advanced/metastatic 1L; KIT/PDGFRA imatinib-sensitive)
Drugs + NSZU
  • Imatinib (DRUG-IMATINIB) 400 mg PO once daily with food + large glass of water (KIT exon 11; PDGFRA non-D842V exon 18; PDGFRA exon 12/14) · Continuous, until progression or unacceptable toxicity · PO ✓ NSZU covered
Reason
Primary current-line option selected by ALGO-GIST-1L at step 3.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Aggressive plan
Indication
IND-GIST-1L-AVAPRITINIB-PDGFRA-D842V
Regimen
Avapritinib monotherapy (GIST advanced/metastatic 1L; PDGFRA D842V)
Drugs + NSZU
  • Avapritinib (DRUG-AVAPRITINIB) 300 mg PO once daily on empty stomach (≥1 h before / ≥2 h after food) · Continuous, until progression or unacceptable toxicity · PO ✗ Not registered in UA
Reason
Current-line alternative presented for HCP consideration

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track
  • PDGFRA D842V substitution mutation in advanced or metastatic GIST. The PDGFRA D842V variant accounts for approximately 6-7% of all GIST and is the most common PDGFRA exon 18 mutation (~65-70% of PDGFRA-mutant GIST). D842V confers primary resistance to imatinib, sunitinib, and regorafenib due to steric interference with drug binding at the activation loop. The type I kinase inhibitor avapritinib binds the active conformation of PDGFRA D842V and achieves ORR ~88% (NAVIGATOR phase 1; Heinrich CANCER DISCOV 2020) and confirmed ORR ~91% in the phase 3 NAVIGATOR expansion cohort. Imatinib is ineffective (historical ORR <10% for D842V) and must not be used as 1L for confirmed D842V-mutant GIST. Fires to route ALGO-GIST-1L step 1 to avapritinib (IND-GIST-1L- AVAPRITINIB-PDGFRA-D842V) instead of imatinib (IND-GIST-1L-IMATINIB). NCCN GIST 2025 Category 1 preferred: avapritinib 300 mg PO QD for PDGFRA D842V-mutant unresectable/metastatic GIST. Detection: PDGFRA D842V is detectable on targeted NGS, hotspot PCR, or PDGFRA-specific IHC (D842V antibody). Tissue or ctDNA-based molecular testing of all GIST at diagnosis is standard of care per NCCN GIST 2025. PDGFRA non-D842V exon 18 mutations (e.g., D842del, DI842-843IM): intermediate imatinib sensitivity — these are NOT covered by this RF. The RF fires exclusively on the D842V substitution. Non-D842V exon 18 PDGFRA mutations route to imatinib (ALGO-GIST-1L step 2 default path).
    W5c RF authoring. Converts free-text `{condition: "PDGFRA D842V mutation positive"}` in ALGO-GIST-1L step 1 into a formal RF entity. Clinical rationale: PDGFRA D842V confers primary resistance to all approved TKIs except avapritinib…
    RF-GIST-PDGFRA-D842VSRC-NCCN-GIST-2025SRC-NAVIGATORSRC-VOYAGER

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-GIST-1L-IMATINIB)
  • Do NOT start imatinib in PDGFRA D842V GIST — it is intrinsically resistant; route to avapritinib.
  • Do NOT use imatinib 400 mg/day for KIT exon 9 — escalate to 800 mg/day from start.
  • Do NOT skip mutation testing (KIT/PDGFRA NGS) prior to 1L systemic therapy — genotype determines drug + dose.
Aggressive plan (IND-GIST-1L-AVAPRITINIB-PDGFRA-D842V)
  • Do NOT use imatinib (any dose) for PDGFRA D842V — intrinsic resistance.
  • Do NOT start avapritinib without baseline brain MRI — cerebral microbleed surveillance is required (boxed warning).
  • Do NOT continue avapritinib through gr ≥2 cognitive AEs without dose reduction (300 → 200 mg).

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Avapritinib monotherapy (GIST advanced/metastatic 1L; PDGFRA D842V)
28-day cycles × Continuous until progression

MDT brief

Discussion questions (1, 0 blocking)

MDT talk tree (3 steps)

#OwnerTopicAction
1hematologistStaging / disease burden What is the current LDH? Marker of tumor burden and transformation.
2clinical_pharmacistSpecialist review Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
3molecular_geneticistSpecialist review Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

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.

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: 2/2 known (100%), 0 missing, 0 default-track gaps
  • Unevaluated RedFlags: RF-GIST-FRAILTY-AGE, RF-GIST-HIGH-RISK-BIOLOGY, RF-GIST-INFECTION-SCREENING, RF-GIST-ORGAN-DYSFUNCTION, RF-GIST-PDGFRA-D842V, RF-GIST-TRANSFORMATION-PROGRESSION
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: 2026-08-17.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT04181970Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORKN/ARECRUITINGGrupo Espanol de Investigacion en Sarcomas
NCT06380816A Phase I/II Trial of UCB4594 in Participants With Advanced CancerPHASE1 / PHASE2RECRUITINGCancer Research UKSingle country
NCT07406633KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)PHASE2RECRUITINGKumquat Biosciences Inc.Small N (<50) Surrogate endpoint only Single country
NCT07171203Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal TumorPHASE1RECRUITINGUniversity of California, San DiegoPhase 1 only Small N (<50) Single country
NCT07559864Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard TreatmentPHASE2RECRUITINGJian LiSurrogate endpoint only Single country
NCT05751733Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GISTNARECRUITINGXiangya Hospital of Central South UniversitySurrogate endpoint only Single country
NCT04557969Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic AnalysisN/ARECRUITINGNational Cancer Institute (NCI)Surrogate endpoint only Single country
NCT053855495 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High RiskPHASE2RECRUITINGAsan Medical CenterSmall N (<50) Surrogate endpoint only Single country
NCT05464875A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal TumorsN/ARECRUITINGXinhua Zhang, MDSurrogate endpoint only Single country
NCT07673861Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer PatientsNARECRUITINGRoyal Marsden NHS Foundation TrustSingle 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
Standard plan
Imatinib (GIST advanced/metastatic 1L; KIT/PDGFRA imatinib-sensitive) (REG-IMATINIB-GIST-1L)
✓ registered✓ covered₴-? — verify pathwayNSZU 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 pathwaynot 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.