A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 528
- 试验地点
- 26
- 主要终点
- Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
研究概览
简要总结
This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components.
- •Has not receiving systemic therapy for local advanced/metastatic disease.
- •At least has one measurable lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Adequate laboratory indicators.
- •Agree to provide at least 5 slices tumor tissue samples for biomarker detection.
- •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.
- •Understood and signed an informed consent form.
排除标准
- •Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.
- •Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy.
- •Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders.
- •Has participated in other clinical trials within 30 days before randomization.
- •Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
- •Pregnant or lactating women.
- •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)
Sunitinib Malate Capsules
Sunitinib malate capsule 50mg administered orally, once daily in 28-day cycle(14 days on treatment from Day 1-14, 14 days off treatment from day 15-28).
干预措施: Sunitinib (Drug)
结局指标
主要结局
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
时间窗: up to 60 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
次要结局
- Progression free survival (PFS) evaluated by investigator(up to 60 weeks)
- Overall survival (OS)(up to 60 weeks)
- Disease control rate（DCR）(up to 60 weeks)
- Duration of response（DOR）(up to 60 weeks)
- Progression-free survival at 12 months(up to 12 months)
- Overall survival at 12 months(up to 12 months)
- Overall survival at 24 months(up to 24 months)