Ireland
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Recruiting Not applicable

Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST

NCT06507683 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-05-28
Last updated
2024-07-18

Condition(s) studied

Gastrointestinal Stromal Tumors

Investigational drug(s) / intervention(s)

simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib

simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib: A cumulative radiation dose of 50 to 70 Gy is administered in 25-30 fractions, 5 fractions per week, to the target lesion(s). ripretinib: oral 150mg QD

Study summary

The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Voluntary participation and signed informed consent; * age: 18 to 75 years, Male or female * Patients with histologically confirmed GIST and Imaging evaluated as unresectable recurrent and metastatic disease or locally advanced. * ECOG Performance Score: 0-2 * Subjects who have progressed or documented intolerance after previous first-line, second-line, and third-line treatments. * At least one measurable lesion in the abdominal or pelvic cavity that has progressed after frontline treatment * Adequate organ function and bone marrow reserve Exclusion Criteria: * estimated life-expectancy less than 3 months. * Patients who have received previous radiotherapy to the proposed radiotherapy site, or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent organs, and who are considered unsuitable for radiotherapy after MDT discussion * Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks. * If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period

Primary outcome measure(s)

  • Time to disease progression of irradiated lesions — Approximately 12 months since the first subject enrolled
    Time from start of radiotherapy to progression of irradiated lesions

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06507683 on ClinicalTrials.gov ↗ ← All trials in China