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Clinical Trials in China / NCT04523272
Active, not recruiting Phase 3

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

NCT04523272 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 3
Started
2020-08-25
Last updated
2024-10-15

Condition(s) studied

Advanced Renal Cancer

Investigational drug(s) / intervention(s)

TQB2450 →Anlotinib →Sunitinib →

TQB2450: 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.

Anlotinib: A multi-target receptor tyrosine kinase inhibitor.

Sunitinib: A multi-target receptor tyrosine kinase inhibitor.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
The Second Affiliated Hospital of Anhui Medical University Hefei Anhui
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality
China-Japan Friendship Hospital Beijing Beijing Municipality
Peking Union Medical College Hospital Beijing Beijing Municipality
Peking University First Hospital Beijing Beijing Municipality
Beijing Cancer Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Chinese PLA General Hospital Beijing Beijing Municipality
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University Chongqing Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Fujian Provincial Hospital Fuzhou Fujian
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
First Hospital of Lanzhou University Lanzhou Gansu
Sun Yat-sen of Cancer Center Guangzhou Guangdong
The Affiliated Tumor Hospital of Harbin Medical University Harbin Heilongjiang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Hunan Cancer Hospital Changsha Hunan
The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
Jiangxi Cancer Hospital Nanchang Jiangxi
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
The Second Hospital of Dalian Medical University Dalian Liaoning
Liaoning Cancer Hospital & Institute Shenyang Liaoning
Qilu Hospital of Shandong University Jinan Shandong
Yantai Yuhuangding Hospital Yantai Shandong
Tenth People's Hospital of Tongji University Shanghai Shanghai Municipality
Shanghai General Hospital Shanghai Shanghai Municipality
The Second Affiliated Hospital of Xi 'an Jiaotong University Xi’an Shanxi
The First Affiliated Hospital of PLA Air Force Military Medical University Xi’an Shanxi
West China Hospital of Sichuan University Chengdu Sichuan
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality
Second Hospital of Tianjin Medical University Tianjin Tianjin Municipality
First Affiliated Hospital,School of Medicine,Shihezi University Shihezi Xinjiang
The Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
Cancer Hospital of The University of Chinese Academy of Sciences Hangzhou Zhejiang
The First Hospital of Jiaxing Jiaxing Zhejiang

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04523272 on ClinicalTrials.gov ↗ ← All trials in China