Cervical/Endometrial Cancer
Conditions
Interventions
Experimental group:Chemotherapy + targeted + immunotherapy
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma, neuroendocrine carcinoma) diagnosed by pathology at the initial treatment; Endometrial cancer (endometrioid adenocarcinoma, clear cell carcinoma, serosa, undifferentiated carcinoma, carcinosarcoma); 3. subjects with stage IVb, recurrent and persistent cervical cancer/endometrial cancer who are not suitable for external radiotherapy; 4. Diagnosed as stage IVb, recurrent, persistent cervical cancer/endometrial cancer by histology and imaging. For metastatic lymph nodes, histology or cytology cannot be obtained. Combining medical history, laboratory tests and imaging tests (such as CT, MRI, PET/CT) can provide clinical diagnosis; At least one measurable lesion (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is >=10mm, and the short diameter of CT scan of lymph node lesions is >=15mm;) 5. ECOG score: 0-1 points; 6. Expected survival period >= 3 months; 7. The damage caused by the subject receiving other treatments has recovered; 8. The subjects in the experimental group should have never received VEGF pathway inhibitors and other anti-angiogenic drugs, such as bevacizumab, sorafenib, sunitinib, apatinib, anlotinib, etc.; 9. The subjects enrolled in the experimental group should have never received immune checkpoint inhibitor drug treatment, such as pembrolizumab, camrelizumab, ipilimumab, etc.; 10. The function of major organs is normal, that is, the following criteria are met: (1) The blood routine examination standards must meet (no blood transfusion and blood products within 14 days): ANC>=1.5x10^9/L; PLT>=80x10^9/L; (2) Biochemical tests should meet the following criteria: TBIL 45 ml/min (Cockcroft -Gault formula); 11. The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have been proven allergic to chemotherapy, bevacizumab, and sintilimab; 2. The subject has any active autoimmune disease or has a 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 complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included); 3. The subject is using immunosuppressive, or systemic, or absorbable topical hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other equivalent therapeutic hormones), and continued use within 2 weeks before enrollment; 4. According to the NYHA standard, the subjects with grade III-IV cardiac insufficiency, or the left ventricular ejection fraction (LVEF) less than 50% indicated by cardiac ultrasound examination; 5. Abnormal coagulation function (INR>1.5 APTT>1.5 ULN), with bleeding tendency; 6. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks; 7. Subjects with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal; hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value ); 8. The subject has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 9. Those with clinical symptoms of ascites, pleural effusion, and pericardial effusion requiring therapeutic puncture or drainage, if the subjects with pleural effusion and pericardial effusion have been observed to be stable for at least 2 weeks after the drainage of the first study drug before the first administration of the study drug, they can be included in the study; 10. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.), arterial or venous thrombotic events have occurred in the past 6 months (until the first SHR-1210 administration); 11. Subjects with high blood pressure that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 12. Subjects with a clear tendency to gastrointestinal bleeding, including the following conditions: subjects with locally active ulcer lesions and fecal occult blood {(++) not eligible}; subjects with a history of melena and hematemesis within 2 months; 13. Subjects with positive urine protein >=++, confirmed that the 24-hour urine protein amount is >=1.0 g; 14. The subject has active infection or unexplained fever >38.5 degrees during the screening period and before the first dose; 15. Subjects with central nervous system metastasis; 16. The subject has previously or concurrently suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 17. Pregnant or lactating subjects; 18. Subjects with a history of psychotropic substance abuse and unable to quit or with mental disorders; 19. According to the judgment of the investigator, subjects with concomitant diseases that seriously endanger the subject's safety or affect the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;disease control rate; | — |
Countries
China
Contacts
Public ContactLi Dapeng
Shandong Cancer Hospital
Outcome results
None listed