Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer

NCT04906993 | Active Not Recruiting Phase 3

• 1 other identifier: SHR-1210-III-329
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria

  up to 2 years

• Overall survival (OS)

  up to 3 years

Secondary Outcomes (7)

• Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria

  up to 2 years

• Objective response rate (ORR) assessed based on RECIST V1.1 criteria

  up to 2 years

• Disease control rate (DCR) assessed based on RECIST V1.1 criteria

  up to 2 years

• Duration of response (DOR) assessed based on RECIST V1.1 criteria

  up to 2 years

• Time to response (TTR) assessed based on RECIST V1.1 criteria

  up to 2 years

Study Arms (2)

camrelizumab combined with famitinib malate

EXPERIMENTAL

Drug: camrelizumab； famitinib malate

platinum-based chemotherapy

ACTIVE COMPARATOR

Drug: platinum-based chemotherapy

Interventions

camrelizumab； famitinib malate DRUG

Camrelizumab intravenously ; Famitinib Orally

camrelizumab combined with famitinib malate

platinum-based chemotherapy DRUG

Physician's choice chemotherapy

platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)
• Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy
• No prior systemic anti-cancer therapy for recurrent/metastatic disease
• According to RECIST v1.1 criteria, the patient must have at least one measurable lesion
• Able to normally swallow drug tablets
• The organ function level is good
• Willing to participate and able to comply with research programme requirements

You may not qualify if:

• Has any malignancy \<5 years prior to study entry.
• Known to have brain or meningeal metastasis
• Known to have autoimmune disease
• Received live vaccinations 4 weeks before randomization or during the study period

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Platinum Compounds

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Study Start: July 23, 2021
• Primary Completion: June 10, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

CN (1)