Cervical carcinoma
Conditions
Sponsors
Shandong Institute of Cancer Prevention and Control
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by pathology at the time of initial treatment; 3. Patients with stage IIIB - IV a cervical cancer; 4. At least one patient with measurable focus (according to the RECIST 1.1 standard, the CT scan length of tumor focus >=10 mm, the CT scan length of lymph node focus >=15 mm); 5. Patients who have not received systematic treatment of cervical cancer before; 6. At least one focus is suitable for patients receiving radiotherapy; 7. ECoG score: 0-1 for patients; 8. Patients with expected survival >=3 months; 9. Patients with normal function of main organs meet the following standards: (1) The blood routine examination standard should be in accordance with (no blood transfusion or blood products within 14 days): ANC>=1.5x10^9/L; PLT>=80x10^9/L. (2) Biochemical examination shall meet the following standards: TBIL 45 ml/min (Cockcroft Gault formula); 10. Those patients who volunteer to join the study and sign the informed consent form, have good compliance and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, no need for any after adulthood Asthma patients who need bronchodilator for medical intervention can not be included; 2. Those who are using immunosuppressant or systemic or absorbable local hormone treatment to achieve immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones) and are still using them within 2 weeks before entering the group; 3. According to NYHA standard, grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) less than 50% indicated by color Doppler echocardiography; 4. Patients with abnormal coagulation (INR > 1.5 or PT > 16S), bleeding tendency or undergoing thrombolysis or anticoagulation; 5. Long term wound or fracture, major surgical operation or serious traumatic injury, fracture or ulcer within 4 weeks; 6. Have congenital or acquired immune function defects (such as HIV infection), or active hepatitis (reference for hepatitis B: patients whose HBV DNA detection value exceeds the upper limit of normal value; reference for hepatitis C: patients whose HCV virus titer or RNA detection value exceeds the upper limit of normal value); 7. Patients have previously received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1; 8. Patients with clinical symptoms of ascites, pleural effusion and pericardial effusion who need therapeutic puncture or drainage, such as those who are stable after drainage of pleural effusion and pericardial effusion for at least 2 weeks before the first application of the study drug, can be included in the study; 9. Patients with known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or patients who have had arteriovenous thrombotic events in the past 6 months (to enrollment); 10. Patients with active infection or fever with unknown cause more than 38.5 degrees during screening and before the first administration; 11. Patients with central nervous system metastasis; 12. Patients with other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 13. Pregnant or lactating women; 14. Patients who have a history of psychoactive drug abuse and unable to give up or have mental disorders; 15. According to the judgment of the principal investigator, patients with serious hazards to the safety of patients or accompanying diseases affecting the completion of the study; 16. The other situation that principal investigator considered not suitable for enrolling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;DCR;QoL; | — |
Countries
China
Contacts
Public ContactDapeng Li
Shandong Provincial Cancer Hospital
Outcome results
None listed