Advanced Renal Cancer Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 418 |
| Est. completion date | June 2023 |
| Est. primary completion date | June 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
| China | China-Japan Friendship Hospital | Beijing | Beijing |
| China | Chinese PLA General Hospital | Beijing | Beijing |
| China | Peking Union Medical College Hospital | Beijing | Beijing |
| China | Peking University First Hospital | Beijing | Beijing |
| China | Peking University Third Hospital | Beijing | Beijing |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | West China Hospital of Sichuan University | Chengdu | Sichuan |
| China | Chongqing University Cancer Hospital | Chongqing | Chongqing |
| China | The Second Hospital of Dalian Medical University | Dalian | Liaoning |
| China | Fujian Provincial Hospital | Fuzhou | Fujian |
| China | Sun Yat-sen of Cancer Center | Guangzhou | Guangdong |
| China | Cancer Hospital of The University of Chinese Academy of Sciences | Hangzhou | Zhejiang |
| China | The Affiliated Tumor Hospital of Harbin Medical University | Harbin | Heilongjiang |
| China | The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | Qilu Hospital of Shandong University | Jinan | Shandong |
| China | Jiangxi Cancer Hospital | Nanchang | Jiangxi |
| China | The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu |
| China | Tenth People's Hospital of Tongji University | Shanghai | Shanghai |
| China | Liaoning Cancer Hospital & Institute | Shenyang | Liaoning |
| China | First Affiliated Hospital,School of Medicine,Shihezi University | Shihezi | Xinjiang |
| China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
| China | The Affiliated Hospital of Xinjiang Medical University | Urumqi | Xinjiang |
| China | The First Affiliated Hospital of PLA Air Force Military Medical University | Xi'an | Shanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | Disease control rate(DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 60 weeks | |
| Secondary | Duration of response(DOR) | The time when the participants first achieved complete or partial remission to disease progression. | up to 60 weeks | |
| Secondary | Progression-free survival at 12 months | Percentage of participants whose PFS has achieved at least 12 months. | up to 12 months | |
| Secondary | Overall survival at 12 months | Percentage of participants whose OS has achieved at least 12 months. | up to 12 months | |
| Secondary | Overall survival at 24 months | Percentage of participants whose OS has achieved at least 24 months. | up to 24 months |