Anlotinib Hydrochloride Capsules Combined With TQB2450 in the Treatment of Endometrial Cancer
NCT Number: NCT06475599
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Endometrial Cancer
Interventions: DRUG: Anlotinib hydrochloride capsule + TQB2450 injection|DRUG: Chemotherapy drug
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-06
Locations: Anhui Provincial Hospital, Hefei, Anhui, 230001, China|Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China|First Hospital of Lanzhou University, Lanzhou, Gansu, 730000, China|Gansu Provincial Cancer Hospital, Lanzhou, Gansu, 730050, China|Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, 510289, China|The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510630, China|Huizhou Central People's Hospital, Huizhou, Guangdong, 516008, China|Jiangmen Central Hospital, Jiangmen, Guangdong, 529030, China|Meizhou People's Hospital, Meizhou, Guangdong, 514031, China|Guigang City People's Hospital, Guigang, Guangxi, 537100, China|Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin, Guangxi, 541000, China|Liuzhou People's Hospital, Liuzhou, Guangxi, 545006, China|Liuzhou Municipal Liutie Central Hospital, Liuzhou, Guangxi, 545007, China|Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China|Hainan Ceneral Hospital, Haikou, Hainan, 570311, China|Tangshan People's Hospital, Tangshan, Hebei, 063000, China|Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, 150081, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 450018, China|Nanyang first People's Hospital National Third Class A Hospital, Nanyang, Henan, 473000, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China|Hubei Cancer Hospital, Wuhan, Hubei, 430079, China|Hunan Cancer Hospital, Changsha, Hunan, 410031, China|The Central Hospital Of Shaoyang, Shaoyang, Hunan, 422000, China|Inner Mongolia Autonomous Region People's Hospital, Hohhot, Inner Mongolia Autonomous Region, 010017, China|Changchun Tumor Hospital, Changchun, Jilin, 130012, China|The first hospital of Jilin University, Changchun, Jilin, 130021, China|Liaoning Cancer Hospital, Shenyang, Liaoning, 110000, China|Shengjing Hospital Of China Medical University, Shenyang, Liaoning, 110000, China|General Hospital Of Ningxia Medical University, Yinchuan, Ningxia, 750001, China|Qinghai Red Cross Hospital, Xining, Qinghai, 810000, China|The Second Affiliated Hospital of Air Force Medical University, Xi'an, Shaanxi, 710038, China|The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shaanxi, 710061, China|Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, 712038, China|Binzhou Medical University Hospital, Binzhou, Shandong, 256600, China|Binzhou People's Hospital, Binzhou, Shandong, 256601, China|Shandong Cancer Hospital, Jinan, Shandong, 250117, China|Affiliated Hospital of Jining Medical University, Jining, Shandong, 272001, China|Linyi Cancer Hospital, Linyi, Shandong, 276000, China|Weifang People's Hospital, Weifang, Shandong, 261000, China|Yidu Central Hospital Of Weifang, Weifang, Shandong, 262500, China|Yantai Yuhuangding Hospital, Yantai, Shandong, 264000, China|Tengzhou Central People's Hospital, Zaozhuang, Shandong, 277500, China|Shanxi Cancer hospital, Taiyuan, Shanxi, 030000, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, 30000, China|Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 830054, China|Yunnan Cancer Hospital, Kunming, Yunnan, 650118, China|Maternal Health School of Medicine Zhejiang University, Hangzhou, Zhejiang, 310006, China|Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China|The Affiliated People's Hospital of Ningbo University, Ningbo, Zhejiang, 315201, China|Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100006, China|Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, China|Chongqing University Cancer Hospital, Chongqing, 400032, China|The Southwest Hospital of Amu, Chongqing, 400038, China|Chongqing University Three Gorges Hospital, Chongqing, 400040, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400072, China|The Affiliated Hospital of Southwest Medical University, Chongqing, 646000, China|Fudan University Shanghai Cancer Center, Shanghai, 200032, China|Shanghai Tenth People's Hospital, Shanghai, 200040, China|Obstetrics & Gynecology Hospital of Fudan University, Shanghai, 200090, China|Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300181, China|Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, 300199, China

Summary:
To demonstrate that anlotinib hydrochloride capsules combined with TQB2450 injection can significantly prolong progression-free survival (PFS) compared with chemotherapy in patients with recurrent or metastatic endometrial cancer that is non- microsatellite instability high (non-MSI-H) or DNA mismatch repair deficient (non-dMMR).

Primary Outcome Measures: Progression-free survival (PFS) assessed by independent imaging review committee (IRC), Progression-free survival (PFS) as assessed by independent imaging review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST1.1) criteria.

Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first., Up to 36 months after study start
Secondary Outcome Measures: Overall survival (OS), Time from randomization to death from any cause., Up to 36 months after study start|Progression-free survival (PFS) assessed by investigators, Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first, was assessed by the investigator according to RECIST 1.1., Up to 36 months after study start|Objective mitigation rate (ORR), According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements, namely the proportion of patients with complete response (CR) and partial response (PR)., Up to 36 months after study start|Duration of Response (DOR), From the time of tumor first evaluated as complete or partial response to the time of first disease progression or death from various causes，if the tumor remission is not confirmed, it can not be used., Up to 36 months after study start|Disease control rate (DCR), According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements, namely the proportion of patients with CR，PR and stable disease (SD)., Up to 36 months after study start|Incidence and severity of abnormal laboratory values, Incidence and severity of laboratory inspection indicators exceed the normal range, Up to 36 months after study start|Incidence and severity of adverse event rate Adverse events (AE), serious adverse event (SAE), The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs), Up to 36 months after study start|Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial, Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial, Up to 36 months after study start|Immunogenicity of TQB2450, Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs), Before administration (-15 minutes) in cycles 1, 2, 5, and 9, and 90 days after the last dose (±7days), each cycle is 21 days|European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Questionnaire: EORTC Quality of Life Questionnaire (QLQ-C30):For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good., Up to 96 weeks|European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L), Questionnaire: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) : The scale has numbers from 0 to 100. 100 represents the best health imaginable. 0 is the worst health imaginable., Up to 96 weeks|European Organization for Research on Treatment of Cancer Endometrial cancer Specific scale QLQ-EN24, Questionnaire: European Organization for Research on Treatment of Cancer Quality of Life questionnaire 24 (QLQ-EN24)：From questions 1 to 24, choose a number from 1 to 4, where 1 means none and 4 means very much., Up to 96 weeks