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

September 9, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jun Guo, Doctor
  • Phone Number: 010-88196348
  • Email: guo307@126.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Not yet recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Dexin Yu, Master
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Zhigang Ji
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Jun Guo, Doctor
        • Contact:
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China, 100853
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Shunchang Jiao, Doctor
      • Beijing, Beijing, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Contact:
        • Principal Investigator:
          • Xiaofeng Zhou, Doctor
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Aiping Zhou, Doctor
        • Contact:
      • Beijing, Beijing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yuan Li
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Tongjian Cui, Master
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen of Cancer Center
        • Contact:
        • Principal Investigator:
          • Fangjian Zhou, Doctor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • The Affiliated Tumor Hospital of Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Jin Wu, Doctor
    • Hunan
      • Changsha, Hunan, China, 410006
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Weiqing Han
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Not yet recruiting
        • The Affiliated Hospital of Nanjing University Medical School
        • Contact:
        • Principal Investigator:
          • Hongqian Guo, Doctor
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xinhua Tu
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Ziling Liu, Doctor
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • Not yet recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Man Li, Doctor
      • Shenyang, Liaoning, China, 110042
        • Not yet recruiting
        • Liaoning cancer Hospital & Institute
        • Principal Investigator:
          • Cheng Fu
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Benkang Shi, Doctor
        • Principal Investigator:
          • Benkang Shi, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Not yet recruiting
        • Tenth People's Hospital of Tongji University
        • Contact:
        • Principal Investigator:
          • Xudong Yao, Doctor
    • Shanxi
      • Xi'an, Shanxi, China, 711400
        • Not yet recruiting
        • The First Affiliated Hospital of PLA Air Force Military Medical University
        • Contact:
        • Principal Investigator:
          • Weijun Qin, Doctor
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Principal Investigator:
          • Pengfei Shen, Doctor
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Principal Investigator:
          • Xiubao Ren, Doctor
    • Xinjiang
      • Shihezi, Xinjiang, China, 832008
        • Not yet recruiting
        • First Affiliated Hospital,School of Medicine,Shihezi University
        • Contact:
          • Ping Gong, Doctor
        • Principal Investigator:
          • Ping Gong, Doctor
      • Urumqi, Xinjiang, China, 830000
        • Not yet recruiting
        • The Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Peng Chen, Master
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Cancer Hospital of The University of Chinese Academy of Sciences
        • Contact:
        • Principal Investigator:
          • Shaoxing Zhu, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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.
up to 60 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) evaluated by investigator
Time Frame: 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.
up to 60 weeks
Overall survival (OS)
Time Frame: 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.
up to 60 weeks
Disease control rate（DCR）
Time Frame: up to 60 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 60 weeks
Duration of response（DOR）
Time Frame: up to 60 weeks
The time when the participants first achieved complete or partial remission to disease progression.
up to 60 weeks
Progression-free survival at 12 months
Time Frame: up to 12 months
Percentage of participants whose PFS has achieved at least 12 months.
up to 12 months
Overall survival at 12 months
Time Frame: up to 12 months
Percentage of participants whose OS has achieved at least 12 months.
up to 12 months
Overall survival at 24 months
Time Frame: up to 24 months
Percentage of participants whose OS has achieved at least 24 months.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

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)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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