Cervical cancer
Conditions
Interventions
Treatment Group:Camrelizumab
Treatment Group:Paclitaxel for Injection (Albumin Bound)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Pathologically confirmed cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma , staged as IIB (R) to IVA (R) according to FIGO (2018); 3. At least one measurable lesion (according to RECIST 1.1 criteria, length of tumor lesion >= 10 mm, or short diameter of lymph node >= 15 mm on CT scan); 4. Performance status score 0-1; 5. Expected survival >= 3 months; 6. No primary/metastatic central nervous system diseases; 7. The patient had not received previous systematic treatment for cervical cancer; 8. Normal organ functions according to the following criteria: (1) Blood routine test standards must be met (no blood transfusion or blood products within 14 days) : 1) Neutrophil absolute count (ANC) >= 1.5x10^9/L; 2) Platelet (PLT) >= 80x10^9/L; 3) Hemoglobin (HGB) >= 9 g/dL; (2) Biochemical tests shall meet the following standards: 1) Liver function: serum total bilirubin (TBIL)= 40 mL/min (standard Cockcroft -Gault formula); 9. Signed informed-consent.
Exclusion criteria
Exclusion criteria: 1. Researcher considered as not suitable for inclusion; 2. Allergic to any drugs in the study; 3. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); medical history of vitiligo; asthma which requires bronchodilators for medical intervention; 4. Congenital or acquired immune deficiency (such as HIV infection, hepatitis B, hepatitis C); 5. Previously treatment with PD-1 and/or PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors; 6. Subjects treated with immunosuppressants can be included if they are medically stable and free of systemic immunosuppressant therapy; 7. Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 8. Patients with uncontrolled heart symptoms or diseases, including Grade III-IV cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) less than 50% as indicated by color doppler echocardiography; 9. Abnormal coagulation function (INR > 1.5, APTT > 1.5 times ULN), bleeding tendency, or arterial-venous thrombosis events occurred in the last 6 months; 10. Patients with ascites, pleural effusion or pericardial effusion with clinical symptoms and requiring therapeutic puncture or drainage. patients with pleural effusion or pericardial effusion who have been stable from drainage at least 2 weeks before the first drug administration can be included; 11. Patients with central nervous system metastasis; 12. A history of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 13. Pregnant or breast-feeding women; 14. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DCR;Safety;QoL; | — |
Countries
China
Contacts
Public ContactKai Chen,Qiwen Li
Sun Yat-sen University Cancer Cent
Outcome results
None listed