Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.
Eligibility Criteria
Inclusion
- Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
- Willing to provide tumor tissue for PD-L1 biomarker analysis.
- At least one measurable lesion according to RECIST 1.1.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- Signing the informed consent forms.
- Adequate bone marrow, liver and renal function.
Exclusion
- Subjects with untreated central nervous system (CNS) metastases.
- Subjects with an active, known or suspected autoimmune disease.
- Subjects with clinically significant cardiovascular and cerebrovascular diseases.
- Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
- Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
- Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT04346381
Start Date
June 5 2020
End Date
June 22 2022
Last Update
September 18 2023
Active Locations (1)
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1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China