Spots Global Cancer Trial Database for Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.
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Trial Identification
Brief Title: Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.
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.
Study ID: NCT05481645
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Taizhou People's Hospital, Taizhou, Jiangsu, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Shandong Cancer Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
Yantai Yuhuangding Hospital, Yantai, Shandong, China
Obstetrics & Gynecology Hospital of Fudan University, Shanghai, Shanghai, China
TianJin Medical University Cancer Institute & Hopspital, Tianjin, Tianjin, China
Contact Details
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