A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
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
1 other identifier
interventional
528
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Longer than P75 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 15, 2024
October 1, 2024
4.8 years
August 20, 2020
October 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
TQB2450 + Anlotinib
EXPERIMENTALTQB2450 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
ACTIVE COMPARATORSunitinib 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. 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. 3. At least has one measurable lesion. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- \. Adequate laboratory indicators. 6. 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.
You may not qualify if:
- \. 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. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, 400000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004, China
First Hospital of Lanzhou University
Lanzhou, Gansu, 730013, China
Sun Yat-sen of Cancer Center
Guangzhou, Guangdong, 510060, China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014, China
Hunan Cancer Hospital
Changsha, Hunan, 410006, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 212028, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, 200072, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710004, China
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, 711400, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000, China
Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
First Affiliated Hospital,School of Medicine,Shihezi University
Shihezi, Xinjiang, 832008, China
The Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, 310000, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
Related Publications (1)
Zhou A, Shen P, Li J, Qu W, Wang Z, Ren X, Li Y, Jiang S, Li G, Zeng Y, Qin W, Wu J, Chen P, Zhou F, Guo H, Ji Z, Wang Y, He Z, Wu J, Shi B, Liu L, Yao X, Ma L, Liu Z, Gou X, Fu B, Wang S, Jiang K, Chong T, Tu X, Zhang X, Yu D, Rexiati M, Xue X, Fei J, Wan J, Jia L, He Y, Cui T, Yang AQ, Guo J, Sheng X. First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma (ETER100): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Sep;26(9):1145-1157. doi: 10.1016/S1470-2045(25)00343-2.
PMID: 40907513DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 21, 2020
Study Start
August 25, 2020
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
October 15, 2024
Record last verified: 2024-10