cervical cancer
Conditions
Interventions
Experimental Group:The treatment regimen of QL1706 combined with neoadjuvant chemotherapy (P-NACT) for 2 courses, with 1 course every 21 days
Sponsors
Nantong Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. clinical diagnosis of stage IIB cervical cancer of IB3, IIA2, and local tumor diameter =4 cm (FIGO, 2019 criteria; staging determined after gynecological examination of the patient by 2 physicians of associate seniority or higher); 2. pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma; 3. Patient's age =18 years and =75 years; 4. ECOG status score =1; 5. Laboratory tests: WBC =3.5×109/L, NEU =1.5×109/L, PLT =80×109/L, serum bilirubin =1.5 times of the high limit of normal value, transaminases =1.5 times of the high limit of normal value, BUN=3.2~7.1mmol/L, Cr=44~97µmol/L; 6. Able to follow up and good compliance; 7. able to sign informed consent, including adherence to the requirements and limitations outlined in the informed consent form and in this protocol. 8. increased availability of PD-L1 testing
Exclusion criteria
Exclusion criteria: 1. any active autoimmune disease or history of autoimmune disease requiring systemic therapy, as follows, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators 2. previous treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the trial's prescribed medication or other monoclonal antibodies; 3. History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C; 4. Receipt of immunosuppressive medication or systemic corticosteroid therapy for the purpose of immunosuppression (>10 mg/day of prednisone or other equivalent medication) within 2 weeks prior to trial dosing; 5. History of other primary malignant tumors; 6. Concurrent participation in other clinical trials; 7. pregnant or breastfeeding female patients; non-surgically sterilized subjects of childbearing potential must agree to use effective contraception during and for 3 months after the end of study treatment; 8. Uncontrolled co-morbidities including, but not limited to: cardiac disorders: New York Heart Association (NYHA) class 2 or higher, severe/unstable angina, myocardial infarction within = 6 months prior to study drug administration, severe arrhythmia requiring medication or intervention; uncontrolled hypertension;; cerebrovascular accidents or brain disorders occurring within = 6 months prior to study drug administration, abnormal adjudication skills; blood systemic disorders: coagulation abnormalities (INR > 2.0, PT > 16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy; abnormalities of hepatic or renal development or history of surgery; any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug; 9. treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose; NOTE: Inactivated seasonal influenza virus vaccine is permitted; 10. patients who have received a previous allogeneic bone marrow transplant or solid organ transplant; 11. drug and/or alcohol abuse; 12. those who are unable or unwilling to sign the informed consent form; 13. patients who, in the judgment of the investigator, are unlikely to comply with the study steps, restrictions, and requirements may not participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PCR;PR;DFS;OS; | — |
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactHe Aiqin
Nantong Tumor Hospital
Outcome results
None listed