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To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3702 tablets+Chemotherapy regimen | Experimental | TQB3702 tablets 200mg, every 4 weeks for a treatment cycle. Chemotherapy regimen:Every 3 or 4 weeks is a treatment cycle, with 6 or 12 cycles of combination therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3702 tablets+Chemotherapy regimen | Drug | TQB3702 tablets: Tyrosine kinase inhibitor; Chemotherapy regimen:inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis; |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Eastern cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3 months;
Histologically confirmed B-cell lymphomas of the following types that meet the 2022 World Health Organization (WHO) diagnostic criteria:
Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at least one previous line of systemic standard therapy
Have at least one measurable lesion.
The main organs function well.
Female subjects of reproductive age should agree to use contraception (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengjun Li, Doctor | Contact | 13642138692 | zengjunli@163.com | |
| Fei Li, Doctor | Contact | 13970038386 | yx021021@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinise Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
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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 |
| Gansu Provincial Cancer Hospital | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| Guigang City People's Hospital | Not yet recruiting | Guigang | Guangxi | 537000 | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| PuYang AnYang District Hospital | Not yet recruiting | Anyang | Henan | 450000 | China |
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| Puyang People's Hospital | Not yet recruiting | Puyang | Henan | 457000 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 457000 | China |
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| Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Tongji Hospital Tongji Medical College of HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441000 | China |
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| Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| Zhuzhou Central Hospital | Not yet recruiting | Zhuzhou | Hunan | 412000 | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 10000 | China |
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| Jiangsu Provincial People's Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The second Hospital of dalian | Not yet recruiting | Dalian | Liaoning | 116000 | China |
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| The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital) | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
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| Affiliated Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250117 | China |
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| Tai'an Central Hospital | Not yet recruiting | Tai’an | Shandong | 271000 | China |
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| Tongji Hospital of Tongji University | Not yet recruiting | Shanghai | Shanghai Municipality | 200063 | China |
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| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| Zigong First People's Hospital | Not yet recruiting | Zigong | Sichuan | 643000 | China |
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| Tianjin People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300122 | China |
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| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300202 | China |
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| Affiliated Tumor Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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