A Prospective, Randomized, Parallel Trial of Famitinib Malate at Different Doses Combined With Camrelizumab for the Treatment of Recurrent and Metastatic Cervical Cancer

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT07143292
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cervical Cancer Metastatic
  • Cervical Cancer Recurrent

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a prospective, randomized, parallel investigation aimed at evaluating different doses of famitinib malate (20mg, 15mg, or 10mg, once daily, respectively) by analyzing the pharmacokinetics, efficacy, safety, and tolerability of famitinib malate combined with camrelizumab at different doses. The feasibility of continuously oral administration combined with camrelizumab in reducing the incidence of adverse events (especially grade ≥3 adverse events) in patients by dose reduction while maintaining comparable efficacy.

Key Dates

Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Famitinib 20 mg QD PO + Camrelizumab 200 mg IV Q3W
  • Experimental: Arm 2
    Famitinib 15 mg QD PO + Camrelizumab 200 mg IV Q3W
  • Experimental: Arm 3
    Famitinib 10 mg QD PO + Camrelizumab 200 mg IV Q3W

Primary Outcome Measure

progression free survival [ Time Frame: up to approximately 2 years ]

Central Contacts

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