Actively Recruiting
Phase 2 Study of Tislelizumab and Anlotinib as Second-Line Treatment for Thymoma and Thymic Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-01
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining tislelizumab with anlotinib as a second-line treatment for patients with thymoma and thymic carcinoma who have experienced disease progression after first-line chemotherapy or chemotherapy combined with immunotherapy. This open-label, single-arm, phase II clinical trial conducted in China plans to recruit 20 patients. The study aims to better understand treatment options for this condition. All participants will receive tislelizumab 200 mg on Day 1 every 3 weeks along with anlotinib given at doses of 12 mg, 10 mg, or 8 mg daily from Day 1 to Day 14 every 3 weeks. Treatment continues until the disease progresses. This study does not include a comparison group and focuses on this combined drug regimen as the experimental intervention. Participants will be monitored for up to two years after enrollment to assess the objective response rate, overall survival, progression-free survival, and duration of response. Assessments include tumor measurement according to RECIST 1.1 criteria, vital organ function tests, and safety evaluations. The study includes regular follow-up visits and requires participants to meet specific health and organ function criteria before joining.
CONDITIONS
Brief Title
Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma
Research Team
W
Wen Gao
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