Table 1.
Inclusion and exclusion criteria
| Inclusion criteria | Exclusion criteria |
| FIGO stage IB3, IIA2 or IIB/IIIC1r (tumour size ≥4 cm) cervical cancer and without any treatment | The active autoimmune disease requires a systemic treatment* |
| Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix | Previous treatment with immune checkpoint inhibitors or hypersensitivity to study drug |
| PD-L1 positive (combined positive score ≥1) | Patients requiring treatment with systemic corticosteroids (over 10 mg/day dose) or immunosuppressants within 14 days before enrolment |
| Women 18–70 years of age | Inoculating live vaccine or attenuated live vaccine within 4 weeks |
| ECOG score 0–1 | History of allogeneic tissue/solid organ transplant |
| WBC ≥3.5×109/L, NEU ≥1.5×109/L, platelet ≥80×109/L; AST and ALT ≤1.5 times normal upper limit; total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤ the upper limit of the normal range | Known active HBV, HCV, or HIV infection |
| Patients who have a serious or uncontrollable disease† | |
| Any primary malignancy within 5 years | |
| Pregnant or lactating female patients | |
| Willing to participate in this study and signed the informed consent | Drug or alcohol abuse |
| Participate in clinical trials at the same time | |
| Patients who observed the rules about the scheduled visit, study schedule and medical examination | Unable or unwilling to sign the informed consent |
| Not eligible for the study judged by researchers |
*As follows but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators.
†Including but not limited to: heart diseases (grade III–IV cardiac insufficiency (NYHA standard)); uncontrolled high blood pressure; cerebrovascular accident or brain disease within 6 months or incapacity; haematological diseases, including abnormal coagulation (INR >2.0, PT >16 s); bleeding tendency, receiving thrombolytic or anticoagulant therapy; organic abnormalities of the liver and kidney or surgical history; any active infection requiring systemic anti-infective therapy within 14 days.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; INR, international normalised ratio; NEU, neutrophils; NYHA, New York Heart Association; PT, prothrombin time; WBC, white blood cell.