UnknownNot Applicable

Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy

China20 participantsStarted 2021-08-01

Plain-language summary

To explore the efficacy and safety of preoperative treatment of potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumor (GIST) after failure of treatment.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
✓. 18 years ≤ age \< 75 years, male or female;
✓. Histopathological examination confirmed the diagnosis of gastrointestinal stromal tumors, and immunohistochemical detection of CD117 and/or DOG-1 positive;
✓. According to the modified RECISTv1.1-GIST-specific (hereinafter referred to as"mRECIST") criteria, the subject has at least one measurable lesion (the long diameter of non-lymph node lesions is ≥ 1.0 cm or ≥ 2 times the scanning slice thickness); the lesions with definite progression after local treatment can also be considered as measurable lesions; the imaging results must be obtained within 21 days before the first dose;
✓. Potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumors who have failed imatinib treatment:
✓. The maximum diameter of a single lesion is ≥ 10 cm;
✓. Organ function damage surgery is required (gastrectomy, total gastrectomy, hepatectomy residual liver body ≤ 50% of the normal liver volume);
✓. Multiple organ resection surgery is required (partial gastrectomy combined with pancreatectomy/splenectomy, pancreaticoduodenectomy and abdominoperineal resection);

Exclusion criteria

✕. Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc.;
✕. Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
✕. Patients with severe mental illness;
✕. The patient has participated in or is participating in other clinical studies , or is taking other TKI agents; has any clinically significant concurrent medical condition such as uncontrolled pulmonary disease, active infection, or any other condition that, in the opinion of the investigator, may affect patient compliance, interfere with interpretation of study results, or expose the patient to safety risks.
✕. Active viral infections such as human immunodeficiency virus, hepatitis B, and hepatitis C
✕. Pregnant or lactating female patients or patients expecting to become pregnant during study treatment
✕. Known hypersensitivity to any component of the study drug.
✕. Gastrointestinal abnormalities, including but not limited to:

What they're measuring

No Evidence of Disease Rate (NED Rate)

Timeframe: baseline

No Evidence of Disease Rate (NED Rate)

Timeframe: within 14 days after surgery

Trial details

NCT IDNCT05132738

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-30

Contact for this trial

Hui Cao, Professor

13918141425 caohuishcn@hotmail.com

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumors trials