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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Renal Cancer
• Intervention / Treatment: Drug: TQB2450; Drug: Anlotinib; Drug: Sunitinib

• Study Type: Interventional
• Enrollment (Actual): 528
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 400000
      • Chongqing University Cancer Hospital
    • Chongqing, Chongqing, China, 400000
      • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital
    • Fuzhou, Fujian, China, 350004
      • The First Affiliated Hospital of Fujian Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730013
      • First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen of Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • The Affiliated Tumor Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430014
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410006
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • The Affiliated Hospital of Nanjing University Medical School
    • Nanjing, Jiangsu, China, 212028
      • Jiangsu Province Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
    • Nanchang, Jiangxi, China, 330038
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116027
      • The Second Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital & Institute
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Yantai, Shandong, China, 264099
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital
    • Shanghai, Shanghai, China, 200072
      • Tenth People's Hospital Of Tongji University
  • Shanxi
    • Xi'an, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi 'an Jiaotong University
    • Xi'an, Shanxi, China, 711400
      • The First Affiliated Hospital of PLA Air Force Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University Cancer Institute & Hospital
    • Tianjin, Tianjin, China, 300211
      • Second Hospital of Tianjin Medical University
  • Xinjiang
    • Shihezi, Xinjiang, China, 832008
      • First Affiliated Hospital,School of Medicine,Shihezi University
    • Urumqi, Xinjiang, China, 830000
      • The Affiliated Hospital of Xinjiang Medical University
    • Ürümqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Cancer Hospital of The University of Chinese Academy of Sciences
    • Jiaxing, Zhejiang, China, 314001
      • The First hospital of Jiaxing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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.; Drug: Anlotinib; A multi-target receptor tyrosine kinase inhibitor.
Active Comparator: 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).	Drug: Sunitinib; A multi-target receptor tyrosine kinase inhibitor.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: TQB2450-III-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No