Key inclusion and exclusion criteria | |
---|---|
Inclusion criteria | Exclusion criteria |
Age between 18 and 75 | Uncontrolled active infection |
Untreated patients with pathologically proven stage III-IVA (2018 FIGO staging system) LACC | Prior malignancies (other than curable non-melanoma skin cancer) within 5 years |
ECOG Performance Status of 0–1 | Uncontrolled hypertension or diabetes, severe comorbidities such as cerebral embolism, cerebral hemorrhage, myocardial infarction or serious arrhythmia within 6 months |
Adequate hematological, renal and hepatic functions: a. Hemoglobin > 8.0 g/dl b. Neutrophils > 2 × 109/L; Leukocytes > 4 × 109/L c. Platelets > 100 × 109/L g. Serum ALT/AST ≤ 2.5× UNL h. Serum Total bilirubin ≤1.5× UNL d. Serum urea nitrogen ≤1.5 × UNL e. Serum creatinine (Cr) ≤ 1.5 × UNL | Patients who need to receive systemic corticosteroids (dose ≥10 mg prednisone qd) or other immunosuppressants within 14 days before enrollment or during the study |
Life expectancy > 6 months | Vaccination of live attenuated vaccine within 30 days before enrollment, or plan to receive live attenuated vaccine during the study; Received therapeutic HPV vaccines after diagnosis of LACC |
Eligible for CCRT assessed by principal investigator | Previous organ transplantation or HIV patients |
No obvious active bleeding | Severe uncontrolled mental illness |
Negative pregnancy test for patients at childbearing age, and voluntarily take effective and reliable contraceptive measures during the trial | Active acute or chronic viral hepatitis B or C. HBV DNA > 2000 IU/ml or 104 copies/ml; HCV RNA > 103 copies/ml |
Written informed consent must be available before study registration | Patients with recurrent or distant metastatic disease |
 | Allergic to macromolecular proteins /monoclonal antibodies, or to any components of chemotherapeutic drugs used in the trial |
 | Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial glucocorticoids or other immunosuppressants |