Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.

Advanced Endometrial Cancer Clinical Trial

Official title: Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Controlled, Phase II Clinical Trial.

Status Recruiting

Clinical Trial Summary

This study plans to enroll 69 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The experimental set is divided into lead-in trial and formal trial. The lead-in trial includes 9 subjects to observe the safety of the combination and determine the dosage of anlotinib dihydrochloride capsules before the formal phase. The formal trial includes 60 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The purpose is to evaluate efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules for first-line treatment and maintenance treatment of patient with advanced endometrial cancer or sarcoma of uterus, and explore biomarkers related to efficacy, mechanism of action, safety and/or pathological mechanisms, the surgical conversion rate. ORR is the primary endpoint.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Endometrial Cancer
• Endometrial Neoplasms
• Sarcoma

• NCT number: NCT05481645
• Study type: Interventional
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Xiaojun Chen, Doctor
• Phone: 021-33189900
• Email: cxjlhjj@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: August 22, 2022
• Completion date: December 2024