A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
- Conditions
- Advanced Renal Cancer
- Interventions
- Registration Number
- NCT04523272
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 528
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Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components.
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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.
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Adequate laboratory indicators. 6. Agree to provide at least 5 slices tumor tissue samples for biomarker detection.
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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.
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Understood and signed an informed consent form.
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Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.
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Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy.
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Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders.
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Has participated in other clinical trials within 30 days before randomization.
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Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQB2450 + Anlotinib TQB2450 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). TQB2450 + Anlotinib 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). Sunitinib Malate Capsules Sunitinib 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).
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) evaluated by Independent Review Committee(IRC) 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 Outcome Measures
Name Time Method Progression free survival (PFS) evaluated by investigator 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 investigator.
Overall survival (OS) up to 60 weeks 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.
Disease control rate（DCR） up to 60 weeks Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of response（DOR） up to 60 weeks The time when the participants first achieved complete or partial remission to disease progression.
Progression-free survival at 12 months up to 12 months Percentage of participants whose PFS has achieved at least 12 months.
Overall survival at 12 months up to 12 months Percentage of participants whose OS has achieved at least 12 months.
Overall survival at 24 months up to 24 months Percentage of participants whose OS has achieved at least 24 months.
Trial Locations
- Locations (26)
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of PLA Air Force Military Medical University
🇨🇳Xi'an, Shanxi, China
First Affiliated Hospital,School of Medicine,Shihezi University
🇨🇳Shihezi, Xinjiang, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-sen of Cancer Center
🇨🇳Guangzhou, Guangdong, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Tenth People's Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
The Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Cancer Hospital of The University of Chinese Academy of Sciences
🇨🇳Hangzhou, Zhejiang, China