Cervical cancer
Conditions
Interventions
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years old; 2. Newly pathologically confirmed cervical squamous carcinoma, adenocarcinoma or adenosquamous carcinoma; FIGO 2018 stage IIIB, ?C1, ?C2 or IVA with tumor > 4cm; 3. Had at least one measurable lesion according to RECIST 1.1 criteria; 4. Without severe hematological, cardiovascular, pulmonary, renal or immune function abnormality and baseline laboratory tests meet the following criteria: HGB >= 90g/L, NEUT >= 2 x 10^9/L, WBC >= 4.0 x 10^9/L, PLT >= 100 x 10^9/L, AST = 6 months; 7. Negative serum or urinary HCG within 72h (postmenopause women do not require this test); 8. Agree to use highly effective contraception during the treatment period; 9. With good compliance and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Uncommon histological types, small cell carcinoma, large cell carcinoma, etc.; 2. Has previously received surgery, pelvic irradiation, chemotherapy, target therapy or immunotherapy to treat cervical cancer; 3. Has bilateral hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy; 4. During period of pregnancy or breastfeeding; 5. Uncontrolled vaginal bleeding; 6. Has a history of HIV infection; 7. Has a history of HBV infection with elevated HBV DNA or HCV infection; 8. Has a severe underlying disease, e.g. infection requiring medicine, congestive heart failure (NYHA III or ?), unstable angina or history of myocardial infarction in the past 3 months; 9. Has a history of additional malignant tumor (except for basal cell carcinoma); 10. Has a history of Crohn disease or ulcerative colitis; 11. Has received other investigational agents with 4 weeks; 12. With known history of allergy to PD-1 antibody; 13. Has any contradiction to the use of cisplatin; 14. Has a history of immune deficiency disease, receiving hormone therapy or other immunosuppressive therapy; 15. Has a history of autoimmune disease that has required systemic therapy in past 2 years; 16. Has had an allogenic tissue/solid organ transplant; 17. Has a history of neurological or mental disorders that affects cognitive ability; 18. Not suitable for participation in the opinion of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;3-year OS;safety; | — |
Countries
China
Contacts
Public ContactLi Xiaofan
Beijing Cancer Hospital
Outcome results
None listed