Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
Trial Parameters
Brief Summary
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
Eligibility Criteria
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