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
Overview
- Phase
- Phase 3
- Intervention
- TQB2450
- Conditions
- Advanced Renal Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 528
- Locations
- 26
- Primary Endpoint
- Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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).
Intervention: TQB2450
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).
Intervention: Anlotinib
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).
Intervention: Sunitinib
Outcomes
Primary Outcomes
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
Time Frame: 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.
Secondary Outcomes
- 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)