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NCT Number: NCT04906993

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

camrelizumab； famitinib malate

Drug

Camrelizumab intravenously ; Famitinib Orally

Platinum-based Chemotherapy

Drug

Physician's choice chemotherapy

Primary outcomes

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

    Time frame: up to 2 years

  2. Overall survival (OS)

    Time frame: up to 3 years

Secondary outcomes

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

    Time frame: up to 2 years

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

    Time frame: up to 2 years

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

    Time frame: up to 2 years

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

    Time frame: up to 2 years

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

    Time frame: up to 2 years

  6. Time to treatment failure (TTF)

    Time frame: up to 2 years

  7. Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
May 28, 2021
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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