A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

Официальное название

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

Обзор

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

Вмешательства

• Препарат 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；

Первичные конечные точки

• Overall response rate (ORR) [Срок оценки: Up to 2 years]
• Complete response rate (CRR) [Срок оценки: Up to 2 years]

Вторичные конечные точки (7)

• Adverse events (AE) and serious adverse events (SAE) [Срок оценки: Baseline to up to 28 days]
• ORR and CRR at the end of combination therapy [Срок оценки: Up to 1 year]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years]
• Duration of response (DOR) [Срок оценки: Up to 2 years]
• Overall survival (OS) [Срок оценки: Up to all-cause death]
• 1-year PFS and OS [Срок оценки: Up to 1 year]
• 2-years PFS and OS [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 30 центров

• Cancer Hospital Chinise Academy of Medical Sciences — Пекин
• Gansu Provincial Cancer Hospital — Lanzhou
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Guigang City People's Hospital — Guigang
• Guangxi Medical University Cancer Hospital — Nanning
• Guangxi Medical University Cancer Hospital — Nanning
• Harbin Medical University Cancer Hospital — Харбин
• PuYang AnYang District Hospital — Anyang
• … и ещё 22 центра

Идентификаторы

NCT: NCT06566586 · TQB3702-II-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗