cervical cancer
Conditions
Interventions
experiment group:tislelizumab combined with platinum-based chemotherapy
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-65 years; 2. Histopathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3. Locally advanced tumors (tumor diameter >= 4 cm) that have not previously received any treatment refer to patients with FIGO stage IB3 and IIA2 cervical cancer (confirmed by imaging); 4. Patients must provide tumor tissue sections during the screening period; formalin-fixed paraffin-embedded tumor histopathological samples or fresh tumor histopathological samples will be sent to the central laboratory for PD-L1 expression detection; 5. ECOG performance status score of 0-1 [see Appendix 2 for details]; 6. Patients' laboratory tests meet the following requirements to confirm adequate organ and hematopoietic function: absolute neutrophil count >= 1.5 x 10^9/L; hemoglobin >= 90 g/L (in the past two weeks without blood transfusion); platelets >= 90 x 10^9/L; serum total bilirubin <+ 1.5 x ULN; AST and ALT <= 1.5 ULN; serum creatinine and urea nitrogen <= upper limit of normal, fasting blood glucose <= 126 mg/dL or <= 7.0 mmol/L; 7. According to the investigator, the patient should be able to follow the study procedures, restrictions and requirements, have good compliance and be willing to maintain contact; 8. Willing to participate in this study, female patients of childbearing age and their families must agree and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subject has received chemoradiotherapy, immunotherapy, traditional Chinese medicine therapy, or surgery for cervical cancer; 2. Participation in a clinical trial with another investigational agent within 28 days prior to the first dose of study drug; or receipt of antineoplastic therapy, including but not limited to chemotherapy, radiation therapy, or targeted therapy; 3. Previous treatment with immune checkpoint drugs; 4. Major surgical procedures (except biopsy) within 4 weeks prior to the first dose of study drug or incomplete healing of surgical incision; 5. Significant pleural effusion, pericardial effusion, or ascites requiring multiple drainages within 2 weeks prior to the first dose of study drug; 6. Any active malignancy except basal cell carcinoma of the skin or carcinoma in situ of the breast following radical surgery; 7. History of active autoimmune diseases or autoimmune diseases that may recur (Appendix 4); patients with the following conditions do not need to be excluded and may continue further screening: (1) Well-controlled type I diabetes; (2) Hypothyroidism (as long as hormone replacement therapy alone is used for treatment); (3) Well-controlled celiac disease; (4) Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia); 8. History of HIV, or severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection. Patients with a history of active tuberculosis infection >= 1 year prior to screening should also be excluded unless evidence suggests appropriate treatment has been completed; 9. HBV DNA >= 10^4 copies/mL at screening; 10. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or any evidence of active pneumonia on chest CT scan within 4 weeks prior to the first dose of study drug; 11. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, congestive heart failure (New York Heart Association Class III or higher heart failure (Appendix 3)); arrhythmia requiring other antiarrhythmic drugs in addition to ß-blockers or digoxin; QTcF interval > 450 milliseconds (ms) by electrocardiogram repeat; hypertension not well controlled by antihypertensive drugs (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg); 12. Abnormal thyroid function is present, and thyroid function cannot be maintained in the normal range with drugs; 13. Use of immunosuppressive agents within 2 weeks prior to the first study drug treatment, excluding topical glucocorticoids or systemic glucocorticoids not exceeding 10 mg/methylprednisone or equivalent doses of other glucocorticoids; 14. Previous allogeneic stem cell transplantation or organ transplantation; 15. Live vaccines within 4 weeks (inclusive) of the first dose of study drug; (Note: Seasonally injected influenza vaccines are generally inactivated and are therefore permitted. Intranasal vaccines are live vaccines and are not allowed); 16. History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins; 17. Any other condition, metabolic disorder or laboratory abnormality, alcohol/drug abuse or dependence that would make the investigator reasonably suspect that the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Incidence of adverse event; | — |
Countries
China
Contacts
Public ContactLiu Wenxin
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed