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.
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;
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;
Parallel
Famitinib + Camrelizumab
DrugFamitinib + Camrelizumab
progression free survival
PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first
objective response rate per RECIST v1.1 by investigator
defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
