A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Renal Cancer

Intervention / Treatment
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* Drug: TQB2450
* Drug: Anlotinib
* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components. 2. Has not receiving systemic therapy for local advanced/metastatic disease. 3. At least has one measurable lesion. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 5. Adequate laboratory indicators. 6. Agree to provide at least 5 slices tumor tissue samples for biomarker detection. 7. 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. 8. Understood and signed an informed consent form. Exclusion Criteria: 1. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease. 2. Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy. 3. Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders. 4. Has participated in other clinical trials within 30 days before randomization. 5. Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period. 6. Pregnant or lactating women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQB2450 + Anlotinib<br>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). | Drug: TQB2450<br>* TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.<br>Drug: Anlotinib<br>* A multi-target receptor tyrosine kinase inhibitor.<br>|
| Active Comparator: Sunitinib Malate Capsules<br>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). | Drug: Sunitinib<br>* A multi-target receptor tyrosine kinase inhibitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) evaluated by Independent Review Committee(IRC) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC. | up to 60 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) evaluated by investigator | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator. | up to 60 weeks | 
| Overall survival (OS) | OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. | up to 60 weeks | 
| Disease control rate（DCR） | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 60 weeks | 
| Duration of response（DOR） | The time when the participants first achieved complete or partial remission to disease progression. | up to 60 weeks | 
| Progression-free survival at 12 months | Percentage of participants whose PFS has achieved at least 12 months. | up to 12 months | 
| Overall survival at 12 months | Percentage of participants whose OS has achieved at least 12 months. | up to 12 months | 
| Overall survival at 24 months | Percentage of participants whose OS has achieved at least 24 months. | up to 24 months |