Status:
ACTIVE_NOT_RECRUITING
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Renal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT04523272
Start Date
August 25 2020
End Date
December 1 2025
Last Update
October 15 2024
Active Locations (39)
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1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032