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NCT Number: NCT07627620

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

This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.

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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 2

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.
  • Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous 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
  • Has adequate organ function.
  • Willing to participate and able to comply with research programme requirements.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Estimated life expectancy of more than 3 months.

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.
  • Known allergies and contraindications to the investigational drug or any of its components.

Treatment and study plan

Camrelizumab

Drug

Intravenous (IV) on Day 1 of each cycle

Famitinib Malate

Drug

Famitinib po qd

Chemotherapy

Drug

Paclitaxel + cisplatin or carboplatin

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: up to 2 years

    Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1.

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: up to 2 years

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

  2. Duration of response (DOR)

    Time frame: Up to 2 years

    Duration of Response per RECIST 1.1.

  3. Time to response (TTR)

    Time frame: up to 2 years

    TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1.

  4. Progression-free survival (PFS)

    Time frame: Up to 2 years

    PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death.

  5. Overall Survival (OS)

    Time frame: Up to 2 years

    OS was defined as the time from the date of first dose until death due to any cause.

  6. Safety

    Time frame: Up to 2 years

    Incidence, type and severity of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Tang

CONTACT

[email protected]

0731-89762071

Sponsors and collaborators

Lead sponsor

Hunan Cancer Hospital

Other

Registry information

Official study title

A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

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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