TQB3702 tablets+Chemotherapy regimen: TQB3702 tablets: Tyrosine kinase inhibitor;
Chemotherapy regimen:inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis;
Study summary
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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:
1. Relapsed/refractory indolent B-cell lymphoma
2. Diffuse large B cell lymphoma(DLBCL)
* 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:
* Have had or are currently suffering from other malignant tumors within 3 years prior to the first medication.
* Known or suspected central nervous system (CNS) aggression.
* Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 3 months before the first treatment;
* Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to ≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1 due to any previous treatment, excluding hair loss and fatigue;
* Have multiple factors that affect oral drug absorption (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
* Received major surgical treatment or significant traumatic injury within 28 days before the start of study treatment;
* Hyperkinetic/venous thrombosis events occurred within 6 months before the first medication;
* Have a history of psychotropic drug abuse and can not quit or have mental disorders;
* Subjects with any severe and/or uncontrolled disease;
* Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks before the first dose, or planned to receive live vaccine or mRNA vaccine during the study;
* Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication;
* Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.
Primary outcome measure(s)
Overall response rate (ORR) — Up to 2 years 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.
Complete response rate (CRR) — Up to 2 years The rate of complete tumor remission
Trial sites (30)
Facility
City
Region
Status
Cancer Hospital Chinise Academy of Medical Sciences
Beijing
Beijing Municipality
Not Yet Recruiting
Gansu Provincial Cancer Hospital
Lanzhou
Gansu
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
Guigang City People's Hospital
Guigang
Guangxi
Not Yet Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Not Yet Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
PuYang AnYang District Hospital
Anyang
Henan
Not Yet Recruiting
Puyang People's Hospital
Puyang
Henan
Not Yet Recruiting
Henan Provincial People's Hospital
Zhengzhou
Henan
Not Yet Recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan
Hubei
Not Yet Recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan
Hubei
Not Yet Recruiting
Xiangyang Central Hospital
Xiangyang
Hubei
Not Yet Recruiting
Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha
Hunan
Not Yet Recruiting
Zhuzhou Central Hospital
Zhuzhou
Hunan
Not Yet Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Inner Mongolia
Not Yet Recruiting
Jiangsu Provincial People's Hospital
Nanjing
Jiangsu
Not Yet Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
The second Hospital of dalian
Dalian
Liaoning
Not Yet Recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
Xi'an
Shaanxi
Not Yet Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Recruiting
Tai'an Central Hospital
Tai’an
Shandong
Not Yet Recruiting
Tongji Hospital of Tongji University
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanxi Cancer Hospital
Taiyuan
Shanxi
Not Yet Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou
Sichuan
Not Yet Recruiting
Zigong First People's Hospital
Zigong
Sichuan
Not Yet Recruiting
Tianjin People's Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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