A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
NCT Number: NCT06566586
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: B-cell Lymphoma
Interventions: DRUG: TQB3702 tablets+Chemotherapy regimen
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12
Locations: Cancer Hospital Chinise Academy of Medical Sciences, BeiJing, Beijing, 100021, China|Gansu Provincial Cancer Hospital, Lanzhou, Gansu, 730000, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510000, China|Guigang City People's Hospital, Guigang, Guangxi, 537000, China|Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China|Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China|Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, 150000, China|PuYang AnYang District Hospital, Anyang, Henan, 450000, China|Puyang People's Hospital, Puyang, Henan, 457000, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 450000, China|Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, 457000, China|Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy, Wuhan, Hubei, 430022, China|Tongji Hospital Tongji Medical College of HUST, Wuhan, Hubei, 430030, China|Xiangyang Central Hospital, XiangYang, Hubei, 441000, China|Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China|Zhuzhou Central Hospital, Zhuzhou, Hunan, 412000, China|The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, 10000, China|Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, 210000, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|The second Hospital of dalian, Dalian, Liaoning, 116000, China|The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital), Xi'an, Shaanxi, 710004, China|Affiliated Cancer Hospital of Shandong First Medical University, Jinan, Shandong, 250117, China|Tai'an Central Hospital, Tai'an, Shandong, 271000, China|Tongji Hospital of Tongji University, Shanghai, Shanghai, 200063, China|Shanxi Cancer Hospital, TaiYuan, Shanxi, 030000, China|The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China|Zigong First People's Hospital, Zigong, Sichuan, 643000, China|Tianjin People's Hospital, Tianjin, Tianjin, 300122, China|Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, 300202, China|Affiliated Tumor Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 830000, China

Summary:
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma

Primary Outcome Measures: Overall response rate (ORR), According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment., Up to 2 years|Complete response rate (CRR), The rate of complete tumor remission, Up to 2 years
Secondary Outcome Measures: Adverse events (AE) and serious adverse events (SAE), Incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators, Baseline to up to 28 days|ORR and CRR at the end of combination therapy, Objective response rate and complete remission rate at the end of combination therapy., Up to 1 year|Progression-free survival (PFS), PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause., Up to 2 years|Duration of response (DOR), The period from the participants first achieving CR or PR to disease progression, Up to 2 years|Overall survival (OS), OS is defined as the time from the first administration to all-cause death, Up to all-cause death|1-year PFS and OS, 1-year Progression-free survival and Overall survival rates, Up to 1 year|2-years PFS and OS, 2-years Progression-free survival and Overall survival rates, Up to 2 years