Clinical trial NCT04523272: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced Renal Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
timeFrame: up to 60 weeks
Secondary outcomes:
measure: Progression free survival (PFS) evaluated by investigator
timeFrame: up to 60 weeks
measure: Overall survival (OS)
timeFrame: up to 60 weeks
measure: Disease control rate（DCR）
timeFrame: up to 60 weeks
measure: Duration of response（DOR）
timeFrame: up to 60 weeks
measure: Progression-free survival at 12 months
timeFrame: up to 12 months
measure: Overall survival at 12 months
timeFrame: up to 12 months
measure: Overall survival at 24 months
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen of Cancer Center
state: Guangdong
city: Harbin
country: China
facility: The Affiliated Tumor Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Tenth People's Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of PLA Air Force Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Tianjin
country: China
facility: Second Hospital of Tianjin Medical University
state: Tianjin
city: Shihezi
country: China
facility: First Affiliated Hospital,School of Medicine,Shihezi University
state: Xinjiang
city: Urumqi
country: China
facility: The Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Cancer Hospital of The University of Chinese Academy of Sciences
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
Study officials:
References: