Phase II Study of Lenvatinib for Advanced Gastrointestinal Stromal Tumors After Imatinib, Sunitinib, and Regorafenib Treatment Failure

What this Trial Is About

Researchers are studying the safety and effectiveness of lenvatinib in patients with metastatic or advanced gastrointestinal stromal tumors GIST who have not responded to prior treatments with imatinib, sunitinib, and regorafenib. These patients often develop resistance to standard therapies, creating a need for new treatment options. Lenvatinib is a multi-targeted drug that works against several key pathways involved in tumor growth and blood vessel formation. Participants in this trial will receive lenvatinib capsules orally once daily. The dose depends on body weight 12 mg daily for patients weighing 60 kg or more, and 8 mg daily for those under 60 kg. Each treatment cycle lasts 28 days. This is a single-arm, phase II study conducted at a single center, focusing on patients who have progressed after three prior therapies. During the study, participants will be closely monitored for disease control at 12 weeks, which is the primary outcome measure. Researchers will assess tumor response and safety throughout the treatment. Participants must meet specific health and laboratory criteria before enrollment and will be followed carefully to evaluate how well they tolerate the therapy and its impact on their disease. The study is expected to continue until December 2027.

Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients