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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2022-06-22

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

Intravenous (IV) camrelizumab on Day 1 of each cycle

Famitinib

Intervention Type DRUG

famitinib po qd

Interventions

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Camrelizumab

Intravenous (IV) camrelizumab on Day 1 of each cycle

Intervention Type DRUG

Famitinib

famitinib po qd

Intervention Type DRUG

Other Intervention Names

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SHR-1210

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 39872476 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38388167 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37415845 (View on PubMed)

Other Identifiers

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SHR-1210-II-215

Identifier Type: -

Identifier Source: org_study_id

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