Lead Sponsor

RenJi Hospital

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

No

•1. Age between 18 and 75;
•2. Untreated patients with pathologically proven locally advanced cervical cancer;
•3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
•4. 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
•5. Life expectancy \> 6 months
•6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;
•7. No obvious active bleeding;
•8. Written informed consent must be available before study registration.

•1. Recurrent or distant metastatic disease;
•2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
•3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
•4. 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;
•5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
•6. Previous organ transplantation or HIV patients;
•7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
•8. 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.

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