Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer

Prior treatment

• Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
• Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
• Previous organ transplantation or HIV patients;

Other illness

• Recurrent or distant metastatic disease;
• Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
• Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
• Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
• Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.

• Age between 18 and 75;
• Untreated patients with pathologically proven locally advanced cervical cancer;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Adequate hematological, renal and hepatic functions:
  • 4.1 Hemoglobin \> 8.0 g/dl 4.2 Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L 4.3 Platelets \> 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL
• Life expectancy \> 6 months
• Eligible for concurrent chemoradiotherapy assessed by principle investigator;
• No obvious active bleeding;
• Written informed consent must be available before study registration.