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

Primary Purpose

Advanced Renal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TQB2450
Anlotinib
Sunitinib
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Renal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Anhui Medical University
  • Cancer Hospital Chinese Academy of Medical Sciences
  • China-Japan Friendship Hospital
  • Peking Union Medical College HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • Peking University Third Hospital
  • Chinese PLA General Hospital
  • Chongqing University Cancer HospitalRecruiting
  • Fujian Provincial Hospital
  • Sun Yat-sen of Cancer Center
  • The Affiliated Tumor Hospital of Harbin Medical University
  • Hunan Cancer Hospital
  • The Affiliated Hospital of Nanjing University Medical School
  • Jiangxi Cancer Hospital
  • The First Hospital of Jilin University
  • The Second Hospital of Dalian Medical University
  • Liaoning Cancer Hospital & Institute
  • Qilu Hospital of Shandong University
  • Tenth People's Hospital of Tongji University
  • The First Affiliated Hospital of PLA Air Force Military Medical University
  • West China Hospital of Sichuan University
  • Tianjin Medical University Cancer Institute & HospitalRecruiting
  • First Affiliated Hospital,School of Medicine,Shihezi University
  • The Affiliated Hospital of Xinjiang Medical University
  • Cancer Hospital of The University of Chinese Academy of Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TQB2450 + Anlotinib

Sunitinib Malate Capsules

Arm Description

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 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of response（DOR）
The time when the participants first achieved complete or partial remission to disease progression.
Progression-free survival at 12 months
Percentage of participants whose PFS has achieved at least 12 months.
Overall survival at 12 months
Percentage of participants whose OS has achieved at least 12 months.
Overall survival at 24 months
Percentage of participants whose OS has achieved at least 24 months.

Full Information

First Posted
August 20, 2020
Last Updated
September 9, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04523272
Brief Title
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Renal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB2450 + Anlotinib
Arm Type
Experimental
Arm Description
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).
Arm Title
Sunitinib Malate Capsules
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
TQB2450
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
A multi-target receptor tyrosine kinase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
A multi-target receptor tyrosine kinase inhibitor.
Primary Outcome Measure Information:
Title
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
Time Frame
up to 60 weeks
Secondary Outcome Measure Information:
Title
Progression free survival (PFS) evaluated by investigator
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.
Time Frame
up to 60 weeks
Title
Overall survival (OS)
Description
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.
Time Frame
up to 60 weeks
Title
Disease control rate（DCR）
Description
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 60 weeks
Title
Duration of response（DOR）
Description
The time when the participants first achieved complete or partial remission to disease progression.
Time Frame
up to 60 weeks
Title
Progression-free survival at 12 months
Description
Percentage of participants whose PFS has achieved at least 12 months.
Time Frame
up to 12 months
Title
Overall survival at 12 months
Description
Percentage of participants whose OS has achieved at least 12 months.
Time Frame
up to 12 months
Title
Overall survival at 24 months
Description
Percentage of participants whose OS has achieved at least 24 months.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo, Doctor
Phone
010-88196348
Email
guo307@126.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dexin Yu, Master
Email
yudx_urology@126.com
First Name & Middle Initial & Last Name & Degree
Dexin Yu, Master
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiping Zhou, Doctor
Phone
010-87788800
Email
zhouap1825@126.com
First Name & Middle Initial & Last Name & Degree
Aiping Zhou, Doctor
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhou, Doctor
Email
dzsfighting@126.com
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhou, Doctor
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Ji
Email
jizhigang@pumch.cn
First Name & Middle Initial & Last Name & Degree
Zhigang Ji
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhisong He
Email
wyj7074@sohu.com
First Name & Middle Initial & Last Name & Degree
Zhisong He
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Doctor
Phone
010-88196348
Email
guo307@126.com
First Name & Middle Initial & Last Name & Degree
Jun Guo, Doctor
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lulin Ma
Email
malulin901@126.com
First Name & Middle Initial & Last Name & Degree
Lulin Ma
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunchang Jiao, Doctor
Email
jiaosc@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Shunchang Jiao, Doctor
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Li
Email
596363075@qq.com
First Name & Middle Initial & Last Name & Degree
Yuan Li
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongjian Cui, Master
Email
fjslctj@163.com
First Name & Middle Initial & Last Name & Degree
Tongjian Cui, Master
Facility Name
Sun Yat-sen of Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangjian Zhou, Doctor
Email
zhoufj@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Fangjian Zhou, Doctor
Facility Name
The Affiliated Tumor Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Wu, Doctor
Email
w.u_jin@163.com
First Name & Middle Initial & Last Name & Degree
Jin Wu, Doctor
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiqing Han
Email
md70210@sina.com
First Name & Middle Initial & Last Name & Degree
Weiqing Han
Facility Name
The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongqian Guo, Doctor
Email
gymwpi@126.com
First Name & Middle Initial & Last Name & Degree
Hongqian Guo, Doctor
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhua Tu
Email
zhou629812@163.com
First Name & Middle Initial & Last Name & Degree
Xinhua Tu
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziling Liu, Doctor
Email
drzilingliu@163.com
First Name & Middle Initial & Last Name & Degree
Ziling Liu, Doctor
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116027
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Li, Doctor
Email
dyeyliman@sohu.com
First Name & Middle Initial & Last Name & Degree
Man Li, Doctor
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Fu
Email
13840219900@163.com
First Name & Middle Initial & Last Name & Degree
Cheng Fu
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benkang Shi, Doctor
First Name & Middle Initial & Last Name & Degree
Benkang Shi, Doctor
Facility Name
Tenth People's Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xudong Yao, Doctor
Email
yaoxudong67@sina.com
First Name & Middle Initial & Last Name & Degree
Xudong Yao, Doctor
Facility Name
The First Affiliated Hospital of PLA Air Force Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
711400
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijun Qin, Doctor
Email
qinweij@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Weijun Qin, Doctor
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Shen, Doctor
Email
cdhx510@163.com
First Name & Middle Initial & Last Name & Degree
Pengfei Shen, Doctor
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiubao Ren, Doctor
Email
renxiubao@tjmuch.com
First Name & Middle Initial & Last Name & Degree
Xiubao Ren, Doctor
Facility Name
First Affiliated Hospital,School of Medicine,Shihezi University
City
Shihezi
State/Province
Xinjiang
ZIP/Postal Code
832008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Gong, Doctor
First Name & Middle Initial & Last Name & Degree
Ping Gong, Doctor
Facility Name
The Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Chen, Master
Email
chenpeng9@126.com
First Name & Middle Initial & Last Name & Degree
Peng Chen, Master
Facility Name
Cancer Hospital of The University of Chinese Academy of Sciences
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoxing Zhu, Doctor
Email
zsxing2005@126.com
First Name & Middle Initial & Last Name & Degree
Shaoxing Zhu, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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