Cervical cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab plus Chemotherapy
Sponsors
Qilu Hospital of Shandong University(Qingdao)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Previously untreated. 2.FIGO Stage IB3, IIA2, or stage IIB/IIIC1r with a tumor diameter >=4 cm. 3 . Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 4. ECOG Performance Status of 0 or 1. 5. Age >=18 years. 6. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 7. Adequate organ function, including bone marrow hematopoiesis, hepatic, and renal function. 8. Adequate coagulation function, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 times the upper limit of normal (ULN). 9. Myocardial enzyme spectrum within normal limits (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator's comprehensive judgment are also eligible). 10. Non-sterile or women of childbearing potential must agree to use a highly effective method of contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 6 months after the last dose. A negative serum or urine pregnancy test result within 7 days before the first dose is required for women of childbearing potential. Must not be lactating.
Exclusion criteria
Exclusion criteria: 1. Patients with infectious diseases requiring systemic antibiotic therapy. 2 . Patients who are HIV-positive, or have active hepatitis or syphilis. 3. Patients with concurrent other malignancies. 4. Patients with psychiatric disorders, or those who are unable or unwilling to comply with the study protocol. 5 . Patients with a history of organ transplantation, autoimmune diseases, idiopathic pulmonary fibrosis, organizing pneumonia, major cardio- or cerebrovascular diseases, unstable arrhythmias, or unstable angina. 6 . Prior treatment with any agent targeting tumor immune mechanisms, including but not limited to: immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or cellular immunotherapy. 7. Any active malignancy within 10 mg daily prednisone or equivalent) or other immunosuppressive medications within = Grade 2 peripheral neuropathy per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 12. Administration of any live vaccine within <=4 weeks before enrollment. 13. Any other underlying medical condition (including laboratory abnormalities), risk factor, alcohol or drug abuse or dependence that, in the investigator's judgment, would preclude the administration of the study drug, interfere with the interpretation of drug toxicity or adverse events (AEs), or lead to inadequate compliance or compromised study conduct. 14. Concurrent participation in another therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate;Deepness of response;Treatment-Related Adverse Events; | — |
Countries
China
Contacts
Public ContactPeihai Zhang
Qilu Hospital of Shandong University(Qingdao)
Outcome results
None listed