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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

The subjects voluntarily joined this clinical study and signed the informed consent form, demonstrating good compliance, be able to cooperate with follow-up visits;

Age: 18 to 75 years old (inclusive, calculated from the date of signing the informed consent);

Cervical cancer confirmed by histopathology, including cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;

It cannot be cured by surgery, radiotherapy or chemoradiotherapy;

Disqualifiers

History (within the past 5 years) or concurrent presence of other untreated malignant tumors, except for cured thyroid cancer, basal cell carcinoma, carcinoma in situ, and breast cancer that has been completely resected and has not recurred for more than 3 years;

Individuals who have previously received famitinib or are allergic to other monoclonal antibodies;

Individuals with any active, known autoimmune diseases;

Participants who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones at a dose >10 mg/day) or other immunosuppressive agents within the past 4 weeks. In the absence of active autoimmune disease, inhaled or topical corticosteroids, as well as adrenal hormone replacement therapy at a dose ≤10 mg/day of prednisone equivalent, are permitted;

Trial design

Treatments tested in this trial

  • Famitinib + Camrelizumab

Treatment groups

120 Participants
are divided into 3 treatment groups

Locations

This trial has no locations