Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma
Trial Parameters
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Brief Summary
It is an open-lable, single-arm, single-center, phase II clinical trial conducted in China, and plan to recruiting 20 patients who were progressed after first line chemotherapy or chemotherapy combined with immunotherapy. The purpose of this study is to evaluate the safety and efficacy of tislelizumab combined with anlotinib as second-line in thymoma and thymic carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited. 2. Histologically or cytologically confirmed thymoma or thymic carcinoma. 3. Disease progression during or after first-line chemotherapy (with or without immunotherapy). 4. At least one measurable solid tumor lesion according to RECIST 1.1 criteria. 5. Estimated survival ≥ 3 months; United States Eastern Cooperative Oncology Group (ECOG) score: 0 or 1 point. 6. Vital organ function meets the following criteria: 1. Hematological examination (no use of any blood components and cell growth factors within 14 days prior to initiation of study treatment): i. neutrophil count (ANC) ≥ 1.5×109/L; ii. platelet count (PLT) ≥100 × 109/L; iii. hemoglobin (Hb) ≥80g/L; 2. total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN, serum albumin (ALB) ≥28g/L; 3. left ventricular ejection fraction (LVEF) ≥50%; 7. Female subjects of childbearing potential must