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Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.
This clinical study plans to enroll 69 endometrial cancer patients and 5-10 uterine sarcoma patients. The trial is divided into a lead-in phase and a main phase. The lead-in phase will include 9 subjects, while the main phase will enroll 60 endometrial cancer patients randomized 1:1. Additionally, 5-10 uterine sarcoma patients will be enrolled. The study aims to evaluate the efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules as first-line treatment, followed by TQB2450 injection monotherapy ± anlotinib hydrochloride capsules as maintenance therapy for advanced endometrial cancer or uterine sarcoma. The study will also explore efficacy-related biomarkers, mechanisms of action, safety and/or pathological mechanisms, and surgical conversion rates. The primary endpoint is ORR (Objective Response Rate).
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