cervical cancer
Conditions
Interventions
the treatment group:Paclitaxel for injection combined with cisplatin chemotherapy and Iparomlimab and Tuvonralimab Injection, for 3 cycles, with 21 days as one cycle
the control group:Paclitaxel for injection combined with cisplatin chemotherapy and the simulant of Iparomlimab and Tuvonralimab Injection, for 3 cycles, with 21 days as one cycle
Sponsors
The Seventh Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-70 years; 2. Diagnosed with stage IB3, IIA2 or IIIC1r (tumor diameter >= 4 cm) cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO) 2018 staging system (staging determined by two physicians at the associate chief physician level or above through gynecological examination), and untreated; 3. At least one target lesion that can be evaluated for tumor response based on the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1); 4. Histologically confirmed squamous cell carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix; 5. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1; 6. Hematological and liver function parameters meeting the following criteria: (1) White blood cell count (WBC) >= 3 × 10^9, (2) Neutrophil count >= 1.5 × 10^9/L, (3) Platelet count (PLT) >= 80 × 10^9/L, (4) AST and ALT <=1.5 × ULN, (5) Total bilirubin <= 1.5 × ULN,(6) Serum creatinine <= 1.5 × ULN, (7) Blood urea nitrogen <= 1.5 × ULN; 7. Subjects must take effective contraceptive measures within 180 days from signing the informed consent form to the end of the last chemotherapy; 8. Voluntary participation in the clinical trial and signing the informed consent form, with the signing of the informed consent form in compliance with Good Clinical Practice (GCP) requirements.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any drug used in the trial and its components or other monoclonal drugs; 2. Active, known or suspected autoimmune diseases requiring systemic treatment, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, asthma requiring bronchodilator treatment; 3. Diseases requiring systemic corticosteroid treatment (more than 10mg prednisone or equivalent per day) or other immunosuppressive drugs (cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks before the first dose of the trial drug and during the study; 4. Previous treatment with immune checkpoint inhibitors, including but not limited to: anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody drugs; 5. Received high-dose systemic corticosteroid treatment within 2 weeks before the first dose of the trial drug; 6. Subjects with any of the following infection conditions: (1) Human immunodeficiency virus (HIV) positive, (2) Positive for hepatitis B surface antigen (HBsAg) and HBV DNA level >= 2000 IU/mL or 10^4 copies/mL, (3) Positive for hepatitis C virus (HCV) antibody and HCV RNA positive subjects, (4) Received anti-tuberculosis treatment within 1 year before screening; 7. Had primary malignant tumors other than cervical cancer or stage I thyroid cancer within 5 years before screening; 8. Pregnant or lactating subjects; 9. Subjects with non-tumor-related severe diseases, functional disorders or corresponding treatment measures in major organs such as the heart, lungs, and digestive tract, as judged by the clinician, including but not limited to: heart disease with NYHA class III-IV heart function, severe/unstable angina pectoris, myocardial infarction within 6 months before screening, significant ventricular arrhythmia, severe heart failure, uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg), severe respiratory depression and hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, severe viral infection and septic shock, severe diabetes, immune-related diseases, hematological diseases or major surgery history; 10. Received live or attenuated vaccines within 4 weeks before the first dose of the trial drug, excluding inactivated seasonal influenza vaccines; 11. Received allogeneic bone marrow transplantation or solid organ transplantation; 12. Drug or alcohol abuse; 13. Participated in other clinical trials within 30 days before screening or during this trial; 14. Subjects deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Partial response rate;Pathological response rate;Pathological complete response rate;Pathological partial response rate;The incidence of surgical complications;Negative margin rate of surgery;Event-free survival;Overall survival;Three-year event-free survival rate;Five-year event-free survival rate;The number of treatment cycles for postoperative adjuvant therapy;Tumor response to adjuvant therapy after surgery; | — |
Countries
China
Contacts
Public ContactMeng Yuan-guang
The Seventh Medical Center of Chinese PLA General Hospital
Outcome results
None listed