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

A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel/Cisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer

To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer

Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.

Inclusion Criteria:

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.

Exclusion Criteria:

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.