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

NCT07143292 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-CervC-II-009
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Cancer Metastatic; Cervical Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• 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

  up to approximately 2 years

Secondary Outcomes (1)

• objective response rate per RECIST v1.1 by investigator

  up to approximately 2 years

Study Arms (3)

Arm 1

EXPERIMENTAL

Famitinib 20 mg QD PO + Camrelizumab 200 mg IV Q3W

Drug: Famitinib + Camrelizumab

Arm 2

EXPERIMENTAL

Famitinib 15 mg QD PO + Camrelizumab 200 mg IV Q3W

Drug: Famitinib + Camrelizumab

Arm 3

EXPERIMENTAL

Famitinib 10 mg QD PO + Camrelizumab 200 mg IV Q3W

Drug: Famitinib + Camrelizumab

Interventions

Famitinib + Camrelizumab DRUG

Famitinib + Camrelizumab

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Those who have received platinum-based systemic therapy for recurrent/metastatic cervical cancer; The number of previous systemic treatment lines is ≤2;
• Has not received bevacizumab treatment in the past;
• It can perform biopsies during the screening period and provide fresh tumor tissues for PD-L1 testing;
• According to the RECIST v1.1 standard, the patient must have at least one measurable lesion;
• ECOG score: 0-1 point;
• Be able to swallow pills normally;
• The expected survival period is ≥3 months;
• The functions of important organs should meet the standards.

You may not qualify if:

• 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;
• Known brain metastases or leptomeningeal metastases (excluding cases with brain metastases that have been stable for ≥4 weeks following radiotherapy or surgery);
• Imaging studies at screening showing tumor invasion of the bladder or rectum, with an assessed risk of perforation by the investigator;
• Spontaneous vaginal bleeding \>30 ml/day within 2 weeks prior to randomization, or visible tumors in the vagina, with a risk of bleeding as assessed by the investigator;
• Clinical symptoms of ascites or pleural effusion requiring drainage, or drainage of pleural or abdominal fluid within 2 weeks prior to randomization; excluding cases with imaging showing minimal ascites or pleural effusion without clinical symptoms;
• History or current presence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pulmonary inflammation (only radiologically demonstrated, those not requiring steroid treatment may be enrolled), drug-induced pneumonia, or active pneumonia during the screening period that the investigator determines precludes enrollment;
• Uncontrolled cardiac symptoms or conditions, such as: (1) NYHA Class 2 or higher heart failure; (2) unstable angina; (3) acute myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• Hypertension that is uncontrolled despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
• Urinalysis indicating urine protein ≥2+, or quantitative urine protein testing confirming 24-hour urine protein quantification ≥1.0 g;
• Currently receiving thrombolytic/anticoagulant therapy, with prophylactic use of low-dose aspirin (≤100 mg/day) or low-molecular-weight heparin (≤40 mg/day);
• Patients who experienced any severe bleeding event of grade 2 or higher according to the CTCAE v5.0 criteria within 4 weeks prior to randomization;
• Patients with imaging evidence of tumor invasion into major vessels or those deemed by the investigator to have a high likelihood of tumor invasion into major vessels during treatment, potentially leading to life-threatening hemorrhage;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Interventions

famitinib; camrelizumab

Central Study Contacts

Huaiwu Lu

CONTACT

+86 020-81332199; luhuaiwu@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 27, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11