Cervical cancer
Conditions
Interventions
Group B:Iparomlimab and Tuvorralimab Group
Group A:Famitinib Combined with Iparomlimab and Tuvorralimab Group
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with cervical cancer who have been diagnosed clinically as advanced IB3, IIA2 and IIB stage or higher, who have not received any treatment or surgery, and who have developed recurrent lesions or whose metastatic lesions have been confirmed by pathology and imaging after not undergoing radiotherapy and chemotherapy. 2. At least one measurable lesion at baseline according to RECIST v1.1 criteria, with lesion size determined by contrast-enhanced magnetic resonance imaging. 3. Pathologically confirmed cervical carcinoma, including squamous cell carcinoma, adenocarcinoma (usual type), and adenosquamous carcinoma. 4. Age >= 18 years. 5. ECOG performance status score of 0-2. 6. Adequate organ function, defined by the following laboratory parameters within specified limits:White blood cell count (WBC) >= 3.5 × 10^9/LAbsolute neutrophil count (ANC) >= 1.5 × 10^9/LPlatelet count (PLT) >= 100 × 10^9/LTotal bilirubin = 50 mL/min (calculated using the Cockcroft-Gault, CKD-EPI, or MDRD formula). 7. Good compliance, enabling follow-up for efficacy and adverse events/reactions as per the protocol. 8. Voluntary provision of signed informed consent, indicating understanding of the study procedures and willingness to comply with all requirements and restrictions, including consent for genetic and biomarker research. 9. Agreement to use effective contraception during the trial and for 6 months after the last dose of study drug (whichever is longer).
Exclusion criteria
Exclusion criteria: 1. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment within the past 2 years (e.g., but not limited to, autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction; 1.asthma requiring bronchodilator intervention). 2. Prior treatment with any immune checkpoint inhibitor (e.g., anti-PD-1, anti-PD-L1 antibodies). Known allergy to any component of the investigational drugs or other monoclonal antibodies. 3. History of human immunodeficiency virus (HIV) infection. Active hepatitis B (HBV-DNA >= 2000 IU/mL or 10^4 copies/mL) or active hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection). 4. Use of immunosuppressive medication or systemic corticosteroids for immunosuppressive purposes (>10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose of study drug. 5. Diagnosis of another primary malignancy within 5 years prior to the first study treatment, except for appropriately treated carcinoma in situ or non-melanoma skin cancer. 6. Administration of any other investigational drug/therapy or participation in another interventional clinical trial within 4 weeks prior to randomization. Participation in observational, non-interventional clinical studies is permitted. 7. Pregnancy or lactation. 8. Uncontrolled co-morbid diseases, including but not limited to: Cardiac disease: NYHA Class II or higher, severe/unstable angina, myocardial infarction within 2.0, PT > 16s), bleeding tendency, or ongoing thrombolytic/anticoagulant therapy. Developmental anomalies or surgical history affecting the liver or kidneys. Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose. 9. Administration of a live or attenuated vaccine within 4 weeks prior to the first dose. Inactivated seasonal influenza vaccination is permitted. 10. History of allogeneic bone marrow transplantation or solid organ transplantation. 11. History of drug and/or alcohol abuse. 12. Any condition that, in the investigator's judgment, renders the patient unlikely to comply with the study procedures, restrictions, and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the short-term and long-term safety of famitinib combined with epalrestat torverelimab in the treatment of patients with advanced and recurrent cervical cancer.;To evaluate the impact of famitinib combined with epalrestat torverelizumab therapy on the objective response rate (ORR) of patients with advanced and recurrent cervical cancer.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the surgical rate, complete pathological response rate (pCR), progression-free survival and overall survival.; | — |
Countries
China
Contacts
Public ContactXipeng Wang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed