NCT06566586招募中2 期
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 29
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Relapsed/refractory indolent B-cell lymphoma
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: TQB3702 tablets+Chemotherapy regimen (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 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)
时间窗: Up to 2 years
The rate of complete tumor remission
次要结局
- ORR and CRR at the end of combination therapy(Up to 1 year)
- Overall survival (OS)(Up to all-cause death)
- Adverse events (AE) and serious adverse events (SAE)(Baseline to up to 28 days)
- Duration of response (DOR)(Up to 2 years)
- 1-year PFS and OS(Up to 1 year)
- 2-years PFS and OS(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
研究者
研究点 (29)
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