cervical carcinoma
Conditions
Interventions
Experimental group:PD-1 inhibitors
Control Group:placebo
Sponsors
Cancer Hospital Affiliated to Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (including 18 years old and 75 years old); 2. Patients with bladder urothelial carcinoma diagnosed by histopathology; 3. Clinical stage II-IIIB, and not suitable for cisplatin chemotherapy (there is a contraindication to cisplatin chemotherapy or the risk of not accepting cisplatin chemotherapy). 4. Have not received anti-tumor radiotherapy and chemotherapy within 1 month before enrollment; 5. Subjects must have measurable lesions, and measurable lesions are defined as: the longest diameter of lymph node lesions in CT cross-sectional images> 1.5 cm; or the longest diameter of primary lesions> 2.0 cm; and biopsy or biopsy pathology positive lesions; 6. The Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1; 7. Expected survival time >= 6 months; 8. Major organ function meets the following criteria 7 days before treatment: (1) Blood routine: hemoglobin >= 80g/L, absolute value of neutrophils >=1.0x10^9/L, platelets >=75x10^9/L; (2) Blood biochemistry: total bilirubin =45ml/min (Cockcroft-Gault formula), international normalized ratio (INR) = 50%. 9. Patients should agree to take effective contraceptive measures during the study period and within 6 months after the end of the study period; 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Participating in other clinical trials; 2. Active tuberculosis disease exists; 3. With central nervous system involvement; 4. Received PD1 inhibitor or PD-L1 inhibitor treatment in the past; 5. There is a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 6. Renal failure requires hemodialysis or peritoneal dialysis; 7. Has a history of other malignant tumors. Except for patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ who have undergone potentially curative treatment and have not had disease recurrence within 5 years of treatment initiation; 8. Subjects who underwent major surgery or had severe trauma had been eliminated for less than 14 days before enrollment; 9. Severe acute or chronic infection requiring systemic treatment; 10. Patients with heart failure (New York Heart Association Criteria Class III or IV) and poor control of coronary artery disease or arrhythmia despite appropriate medical treatment, or a history of myocardial infarction within 6 months prior to screening ; 11. Those who have been vaccinated with live vaccines within 4 weeks before administration of the study drug are allowed to receive inactivated virus vaccines for seasonal influenza by injection, but are not allowed to receive live attenuated influenza vaccines for intranasal administration; 12. Uncontrolled HBV infection, HCV infection; 13. Patients with a history of deep vein thrombosis or pulmonary embolism within the past twelve months; 14. Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc.; 15. The researchers believe that it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactMa Yiming
Cancer Hospital Affiliated to Zhengzhou University
Outcome results
None listed