Cervical Cancer
Conditions
Interventions
Sponsors
Affiliated Hospital of Guilin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. age 18-75 years, FIGO stage IB3-IIB cervical squamous/adenosquamous carcinoma, etc (FIGO 2018 staging ) 2. ECOG PS 0-1, not receiving anti-tumour therapy; 3. PD-L1 CPS >=1; 4. adequate organ function: haematology: absolute neutrophil count (ANC) >= 1.5 x 10?/L, platelets >= 100 x 10?/L, haemoglobin >= 90 g/L (allowed to be met with blood transfusion); liver function: total bilirubin = 60 mL/min; coagulation: INR = 12 weeks; 7. women of appropriate age who have had a negative serum pregnancy test within 7 days prior to enrolment and who are using contraception during the study period and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Active autoimmune disease or immunodeficiency; 2. Prior treatment with PD-1/PD-L1 inhibitors; 3. Severe cardiac, hepatic, or renal impairment; 4. History of or concurrent other malignancies; 5. Radiotherapy, surgery, or investigational drug treatment within 4 weeks prior to enrolment; 6. Cardiovascular disease: NYHA class III-IV heart failure, myocardial infarction within 6 months, or unstable angina pectoris; 7. Interstitial lung disease, active tuberculosis, or pneumonia requiring glucocorticoid therapy; 8. Known hypersensitivity to paclitaxel, platinum-based agents, monoclonal antibodies, or their components; 9. Requiring long-term immunosuppressive therapy (>10 mg/day prednisone equivalent) or systemic corticosteroid treatment; 10. Pregnant or lactating women; or uncontrolled infections (e.g., HBV/HIV); 11. Psychiatric disorders or cognitive impairment precluding treatment compliance and follow-up; 12. Administration of live vaccines (e.g., measles, varicella) within 30 days prior to enrolment; 13. Bone marrow hypofunction; 14. Recent history of infectious or contagious diseases; 15. Individuals contraindicated for the medicinal products (Toripalimab injection, cisplatin, carboplatin, albumin-bound paclitaxel) as per their respective package inserts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactZhu Lin
Department of Radiation Therapy, Affiliated Hospital of Guilin Medical University
Outcome results
None listed