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Table 1 Key eligible criteria of the trial

From: Toripalimab combined with concurrent platinum-based Chemoradiotherapy in patients with locally advanced cervical Cancer: an open-label, single-arm, phase II trial

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

  1. Abbreviations: FIGO International Federation of Gynecology and Obstetrics, LACC locally advanced cervical cancer, ECOG Eastern Cooperative Oncology Group, ULN Upper Limit of Normal, CCRT Concurrent Chemoradiotherapy