Cervical cancer
Conditions
Interventions
experimental group:Radiation therapy + 5 cycles of cisplatin concurrent chemotherapy + Carrizumab
control group:Cisplatin + concurrent radiotherapy
Sponsors
Southern Hospital of Southern Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with cervical squamous cell carcinoma, adenocarcinoma or squamous adenocarcinoma confirmed by pathology; 2. Patients with PD-L1 expression level measured by immunohistochemistry (with 28-8, 22c3 or sp263 antibody); 3. After at least 2 gynecologists who have been engaged in gynecological examination for more than 5 years, they are divided into IIIa and IIIB stage cervical cancer with or without pelvic, groin, retroperitoneal lymph node metastasis and IVA stage according to FIGO 2009. 4. Patients with at least one measurable focus (RECIST 1.1 standard); 5. Patients without central nervous system diseases, including primary and metastatic; 6. Age: 18-70 years old; 7. ECoG PS: 0-2 points; 8. Patients with expected survival >= 3 months; 9. Patients with normal function of main organs: blood routine examination, which should conform to: (1) HB >= 80g/L (2) ANC >= 1.0 * 10^9/L (3) PLT >= 70 * 10^9 / L; biochemical examination shall meet the following standards: (4) Bil = 50ml / min (Cockcroft Gault formula). 10. Patients who have signed informed consent; 11. Patients with follow-up conditions.
Exclusion criteria
Exclusion criteria: 1. In the opinion of the researcher, the case is not suitable for the study; 2. Patients who are known to be allergic to any of the drug ingredients in the study; 3. Patients who are receiving immunosuppressive therapy to achieve the purpose of systemic immunosuppression (prednisone 10mg / day equivalent dose), are still in use 2 weeks before admission; 4. Patients with active autoimmune diseases; 5. Patients with congenital or acquired immune deficiency (such as HIV infection, hepatitis B, hepatitis C); 6. Patients with previous history of other malignant tumors; 7. Patients who had unstable angina, myocardial infarction and grade III-IV cardiac insufficiency (NYHA standard) within 6 months before the study were selected; 8. Patients with distant metastasis; 9. Patients who have a history of psychoactive drug abuse and are unable to give up or have mental disorders; Patients who have participated in clinical trials of other drugs within 10.4 weeks; 11. Patients with other malignant tumor history within 5 years; 12. Patients who have previously received radiotherapy, chemotherapy or targeted treatment for the same disease; 13. Pregnant or nursing patients; 14. According to the judgment of the researcher, there are patients with serious hazards to the safety of patients or accompanying diseases that affect the completion of the study; 15. Patients considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3year-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| mPFS;OS;ORR; | — |
Countries
China
Contacts
Public ContactDehua Wu
Southern Hospital of Southern Medical University
Outcome results
None listed