cervical Cancer
Conditions
Interventions
experiment group:Camrelizumab combined with concurrent Chemoradiotherapy
Sponsors
Meishan Municipal People’s Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Histopathologically(pathologically) confirmed cervical cancer (squamous carcinoma/ adenocarcinoma/adenosquamous carcinoma) with clinical stage IIb-IVA (2018 FIOG staging system); (2) Untreated; (3) ECOG Performance Status of 0–1; (4) Female =18 years old and =75 years old; (5) Vital organ and bone marrow fuction meets the following requirements: Blood routine:WBC=4×10^9/L ,ANC=2 ×10^9/L,PLT=100×10^9/L,HGB=8g/dL; No acute heart failure; Liver function: serum total bilirubin =1.5× ULN,ALT/AST=2.5× ULN;ALB=3g/dL; Renal function:Serum creatinine (Cr)=1.5×ULN, or creatinine clearance = 60ml/min ( calculated by Cockcroft/Gault formula) (6) No obvious active bleeding; (7) Willing to participate in the study and sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol; (8) Life expectancy > 6 months; (9) Radiotherapist assessed patients with no contraindications to radiotherapy; (10) At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1); (11) Negative pregnancy test for patients at childbearing age, and voluntarily take efective and reliable contraceptive measures during the trial.
Exclusion criteria
Exclusion criteria: (1) Any condition requiring systemic treatment with corticosteroids ( prednisone >10mg/ day or equivalent dose of similar drugs ) or other immunosuppressive agents within 14 days prior to the first dose ; (2) History of interstitial lung disease, pneumonitis or pulmonary fibrosis; (3) Infections requiring systemic antibacterial , antifungal , or antiviral treatment , including tuberculosis infections (4) History of malignant tumors; (5) Uncontrolled hypertension or diabetes, severe comorbidities such as cerebral embolism, cerebral hemorrhage, myocardial infarction or serious arrhythmia within 6months; (6) Previous organ transplantation or HIV patients; (7) Severe uncontrolled mental illness; (8) Allergic to macromolecular proteins /monoclonal antibodies, or to any components of chemotherapeutic drugs used in the trial; (9) Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial glucocorticoids or other immuno-suppressants; (10) With distant metastatic lesions, including metastatic lymph nodes above the upper margin of the first lumbar spine and metastatic lymph nodes in the inguinal region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress free survival;overall survival;2 year progress free survival rate;2 year overall survival rate; | — |
Countries
China
Contacts
Public ContactLuo Juan
Meishan Municipal People’s Hospital
Outcome results
None listed