NCT04346381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

April 10, 2020

Last Update Submit

September 14, 2023

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Response Rate

    Up to 18 months

Secondary Outcomes (10)

  • PFS

    Up to 18 months

  • DOR

    Up to 18months

  • DCR

    Up to 18months

  • TTR

    Up to 18 months

  • OS

    Up to 18 months

  • +5 more secondary outcomes

Study Arms (1)

camrelizumab combined with famitinib

EXPERIMENTAL

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

Drug: CamrelizumabDrug: Famitinib

Interventions

CamrelizumabDRUG

Intravenous (IV) camrelizumab on Day 1 of each cycle

Also known as: SHR-1210
camrelizumab combined with famitinib
FamitinibDRUG

famitinib po qd

camrelizumab combined with famitinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (3)

  • 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.

    PMID: 39872476DERIVED

  • 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.

    PMID: 38388167DERIVED

  • 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.

    PMID: 37415845DERIVED

MeSH Terms

Interventions

camrelizumabfamitinib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 15, 2020

Study Start

June 5, 2020

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

CN(1)