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. 2023 May 30;13(5):e067767. doi: 10.1136/bmjopen-2022-067767

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.