Cervical cancer
Conditions
Interventions
Experimental group:Induction therapy, concurrent chemoradiotherapy combined with immunotherapy, immunotherapy maintenance treatment
Control group:Combined chemotherapy and immunotherapy synchronous maintenance treatment
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent must be obtained prior to the implementation of any trial-related procedures; 2. Female, aged 18 to 70 years; 3. Patients with previously untreated locally advanced cervical cancer staged as III-IVA (2014 FIGO staging); 4. At least one measurable lesion with a maximum tumor diameter > 4 cm according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1); 5. ECOG performance status score of 0-1; 6. Expected survival time = 6 months; 7. Sufficient organ function, no serious hematopoietic function abnormalities and abnormalities in heart, lung, liver, kidney functions, and no immune deficiencies. Subjects must meet the following laboratory criteria: 1) Hemoglobin (HGB) >= 90 g/L; 2) Neutrophils (NEUT) >= 1.5 × 10^9/L or white blood cell count (WBC) >= 3 × 10^9/L; 3) Platelets (PLT) >= 100 × 10^9/L; 4) Aspartate aminotransferase (AST) <= 2.5 × ULN; 5) Alanine aminotransferase (ALT) <= 2.5 × ULN; 6) Total bilirubin (TBIL) <= 1.5 × ULN; 7) Serum creatinine (SCr) <= 1.0 × ULN. 8. Women of childbearing potential must have a negative serum or urine HCG test within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered non-childbearing. For women who have undergone confirmed tubal ligation, no pregnancy test is required); 9. Women of childbearing potential must be willing to use medically approved contraceptive measures during the trial.
Exclusion criteria
Exclusion criteria: 1. Malignant tumors of rare pathological types, such as small cell carcinoma, large cell carcinoma, etc.; 2. Patients with bilateral hydronephrosis and hydroureter (eligible if at least one side is relieved after nephrostomy or ureteral stent placement); 3. Patients with uncontrolled massive vaginal bleeding; 4. Diagnosis of malignancies other than cervical cancer within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); 5. Current participation in interventional clinical studies, or treatment with other investigational drugs or use of investigational devices within 4 weeks prior to the first dose; 6. Previous surgical treatment, pelvic radiotherapy, systemic chemotherapy, targeted therapy, or immunotherapy for cervical cancer; 7. Systemic glucocorticoid therapy within 7 days prior to the first study dose (excluding nasal spray, inhaled, or other routes of local glucocorticoid administration) or any other form of immunosuppressive therapy; 8. Clinically uncontrolled pleural effusion/ascites (patients who do not require drainage or whose effusion does not significantly increase 3 days after stopping drainage may be enrolled); 9. Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Known allergy to the active ingredient or excipients of the investigational drug; 11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number above the upper limit of normal as measured by the local laboratory); Note: Patients with hepatitis B who meet the following criteria may also be enrolled: 13. Active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 14. Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated vaccines for seasonal influenza administered within 30 days prior to the first dose are permitted; however, live attenuated influenza vaccines administered intranasally are not allowed. 15. Pregnant or breastfeeding women; 16. Any serious or uncontrolled systemic disease exists, such as: 1) Individuals with active autoimmune diseases or a history of autoimmune diseases, but candidates with the following conditions are allowed to further enroll in screening: well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment, or expected cases that will not relapse without external triggering factors; 2) Individuals with severe cardiovascular diseases, such as heart failure classified as grade 2 or higher by the American New York Heart Association (NYHA), myocardial infarction within the 3 months prior to screening, poorly controlled arrhythmias or unstable angina, severe venous-thrombotic events (such as transient ischemic attacks, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism) occurring within 3 months prior to screening; 3) A history of non-infectious pneumonia requiring glucocorticoid treatment within the year prior to the first administration, or currently having clinically active interstitial lung disease; 4) Active tuberculosis; 5) Acti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Duration of relief;Objective response rate, ORR;Overall survival;Progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactXiaofan Li
Peking University Cancer Hospital
Outcome results
None listed