Phase II Trial of Lenvatinib Mesylate Capsules for Advanced Bone and Soft Tissue Sarcoma After Previous Targeted Therapy Failure

What this Trial Is About

Researchers are evaluating the efficacy and safety of lenvatinib mesylate capsules in patients with metastatic or surgically unresectable bone and soft tissue sarcomas who have previously received multi-target tyrosine kinase inhibitor TKI therapy and did not respond. This open, one-arm Phase II study enrolls 60 patients to assess progression-free survival and objective response rate over approximately 24 months. Participants receive lenvatinib mesylate capsules orally once daily, with the dose depending on body weight 8 mg for those weighing 60 kg or less, and 12 mg for those over 60 kg. The medication is taken about half an hour after meals with warm water, aiming for consistent daily timing. This treatment continues throughout the study period as investigators monitor patients. During the study, participants undergo regular assessments including tumor measurements that meet RECIST 1.1 criteria, laboratory tests to monitor organ and bone marrow function, and evaluations of physical status. Side effects and any toxicities from previous treatments are monitored to ensure safety. The research team tracks how long patients live without disease progression and their tumor response, with the total participation lasting up to about two years.

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma