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OncoMatch/Clinical Trials/NCT05009927

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

Is NCT05009927 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Imatinib tablets for metastatic gastrointestinal stromal tumor (gist).

Phase 2RecruitingCentre Leon BerardNCT05009927Data as of May 2026

Treatment: Imatinib tabletsThis is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST. In the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease. In the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.

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Extracted eligibility criteria

Cancer type

Gastrointestinal Stromal Tumor

Biomarker criteria

Required: KIT expression (immunohistochemical documentation of c-kit (CD117) expression)

immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases

Excluded: PDGFRA D842V

Patient with GIST harboring the mutation D842V in PDGFRA

Disease stage

Required: Stage IV

Metastatic disease required

malignant advanced/metastatic GIST

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: imatinib (imatinib)

Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period

Cannot have received: other approved or investigational antineoplastic agents

Patient concurrently using other approved or investigational antineoplastic agents

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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