Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Solid Tumor

Treatments: Drug: Camrelizumab; Drug: Famitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04346381

SHR-1210-II-215

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
2. Willing to provide tumor tissue for PD-L1 biomarker analysis.
3. At least one measurable lesion according to RECIST 1.1.
4. ECOG performance status of 0 to 1.
5. Life expectancy of more than 12 weeks.
6. Signing the informed consent forms.
7. Adequate bone marrow, liver and renal function.

Exclusion criteria

1. Subjects with untreated central nervous system (CNS) metastases.
2. Subjects with an active, known or suspected autoimmune disease.
3. Subjects with clinically significant cardiovascular and cerebrovascular diseases.
4. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
5. Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
6. Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
7. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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233 participants in 1 patient group

camrelizumab combined with famitinib

Experimental group

Description:

Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.

Treatment:

Drug: Famitinib

Drug: Camrelizumab