Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor
NCT ID: NCT04346381
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
233 participants
INTERVENTIONAL
2020-06-05
2022-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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camrelizumab combined with famitinib
Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.
Camrelizumab
Intravenous (IV) camrelizumab on Day 1 of each cycle
Famitinib
famitinib po qd
Interventions
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Camrelizumab
Intravenous (IV) camrelizumab on Day 1 of each cycle
Famitinib
famitinib po qd
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Ai L, Li Q, Zhang S, Dong Y, Yang M, Li J, Pan Y, Yuan Y, Yi S, Wang J, Cheng Y, Feng J, Gao S, Wang X, Qu S, Zhang X, Lu J, Xiu P, Wang S, Yang X, Yu Y, Liu T. Famitinib plus camrelizumab in patients with advanced colorectal cancer: Data from a multicenter, basket study. Innovation (Camb). 2025 Jan 6;6(1):100745. doi: 10.1016/j.xinn.2024.100745. eCollection 2025 Jan 6.
Ren S, Wang X, Han BH, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS >/=1%: results from a multicenter, open-label, phase 2 trial. J Immunother Cancer. 2024 Feb 21;12(2):e007227. doi: 10.1136/jitc-2023-007227.
Ding X, Hua YJ, Zou X, Chen XZ, Zhang XM, Xu B, Ouyang YF, Tu ZW, Li HF, Duan CY, Zhang WJ, You R, Liu YP, Liu YL, Yang Q, Huang PY, Wang SN, Fan J, Chen MY. Camrelizumab plus famitinib in patients with recurrent or metastatic nasopharyngeal carcinoma treated with PD-1 blockade: data from a multicohort phase 2 study. EClinicalMedicine. 2023 Jun 23;61:102043. doi: 10.1016/j.eclinm.2023.102043. eCollection 2023 Jul.
Other Identifiers
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SHR-1210-II-215
Identifier Type: -
Identifier Source: org_study_id
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