Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial
To explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.
• 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:
‣ Hemoglobin \> 8.0 g/dl
⁃ Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L
⁃ Platelets \> 100 × 109/L
• g. Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) d. Serum ALT/AST ≤ 2.5× UNL e. 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