Cervical cancer
Conditions
Interventions
treatment group:The control group received additional adjuvant therapy with carrillizumab
control group :Receive concurrent chemoradiotherapy
Sponsors
Jiangnan Hospital, the Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with cervical cancer confirmed by pathology; 2. Patients with stage Ib3-IVa (generalized local advanced stage) in 2018 FIGO clinical stage; 3. Patients with expected survival >= 3 months; 4. ECoG score: 0 - 2 for patients; 5. Patients with the following clinical characteristics in line with one article: (1) Aged = 4 cm; (4) The pelvic lymph nodes or paraaortic lymph nodes were positive (PET / CT); (5) SCC antigen >= 4 ng / ml; (6) Hemoglobin at initial diagnosis < 90g / L; 6. Women of childbearing age must have taken reliable contraceptive measures, or carry out pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of the test drug; 7. The subjects voluntarily joined the study, signed the informed consent, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who participated in clinical studies of other drugs within 4 weeks before the start of study treatment; 2. Patients with severe hepatorenal insufficiency who can not receive radiotherapy, chemotherapy and immunotherapy; 3. Patients who have been treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti lymphocyte antigen 4 (CTLA-4) antibody; 4. It is known that the subject has been allergic to macromolecular protein preparation / monoclonal antibody, or to any component of the test drug; 5. Patients with active autoimmune diseases who have received systematic treatment in the past two years (such as corticosteroids or immunosuppressive drugs); 6. Patients who received live vaccination within 30 days before the first study drug treatment; 7. The researcher judges other situations that may affect the clinical research and the judgment of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTDM;OS;ORR;DCR;Adverse events;QoL; | — |
Countries
China
Contacts
Public ContactZhenZhou Yang
Jiang'nan hospital, the Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed