A Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in Unresectable Advanced Gastrointestinal Stromal Tumors

What this Trial Is About

Researchers are investigating whether combining radiotherapy with ripretinib can improve treatment outcomes for patients with unresectable advanced gastrointestinal stromal tumors (GIST) who have not responded to prior treatments. This study aims to find out if this combination can delay the progression of the disease and to assess the safety of this new approach. Ripretinib is currently the standard fourth-line treatment but provides limited progression-free survival, so exploring additional therapies is important to improve patient quality of life and survival. The treatment involves delivering a precise form of radiotherapy called simultaneous integrated boost intensity-modulated radiotherapy, which targets tumors with a total radiation dose between 50 to 70 Gy over 25 to 30 sessions, five sessions per week. Alongside this, patients take oral ripretinib at 150 mg once daily. The study focuses on patients with advanced GIST whose tumors cannot be surgically removed and who have already undergone multiple prior drug treatments. This approach aims to optimize radiation delivery to maximize tumor control while protecting surrounding healthy tissue. Participants will be monitored for about 12 months, during which researchers will evaluate the time until disease progression in treated tumors, overall survival, and the tumor’s response to treatment. Assessments include imaging scans to measure tumor size and progression, along with safety evaluations. The study also tracks the time to progression of any lesions and overall survival. This comprehensive follow-up helps researchers understand the potential benefits and risks of combining radiotherapy with ripretinib in this patient population.

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