A Open-label, Multicenter Phase II Study of TQB2450 Injection or Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 36
- 主要终点
- Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
研究概览
简要总结
This is a study to evaluate the efficacy and safety of TQB2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Understood and signed an informed consent form.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.
- •Has at least one measurable lesion.
- •Agree to provide tumor tissue samples for MSI/MMR status detection.
- •Adequate laboratory indicators.
- •Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.
排除标准
- •1.Concomitant disease and medical history:
- •Has diagnosed and/or treated additional malignancy within 3 years prior to randomization;
- •Pathological diagnosed as uterine sarcoma;
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy.
- •Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study.
- •Has a unhealed wound or fracture for a long time;
- •Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study;
- •Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
- •Has a history of psychotropic substance abuse and unable to quit or mental disorders;
- •Has any serious and / or uncontrolled disease;
- •Tumor-related symptoms and treatment:
- •Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study;
- •Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study;
- •Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs;
- •Has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, Sunitinib, regorafenib, fruquintinib, etc;
- •Has received hormone therapy for endometrial cancer within a week before the first dose ;
- •CT or MRI showed that the tumor had invaded the important blood vessels;
- •Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease;
- •Related to research and treatment:
- •Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
- •Has a history of severe allergic diseases.
- •Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study.
- •Has Participated in other clinical trials within 4 weeks before first dose.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB2450 + Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: TQB2450 (Drug)
TQB2450 + Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib (Drug)
TQB2450
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
干预措施: TQB2450 (Drug)
Anlotinib
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib (Drug)
结局指标
主要结局
Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
时间窗: up to 12 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.
次要结局
- Progression free survival(PFS)(up to 12 months)
- Overall survival(OS)(up to 18 months)
- DOR rate (≥ 6 months)(up to 6 months)
- Overall response rate (ORR) evaluated by investigator(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
- Duration of response (DOR)(up to 12 months)