Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.

Inclusion criteria

• Untreated locally advanced cervical cancer patients with clear pathological diagnosis
• 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Life expectancy > 6 months
• Able to tolerate concurrent chemoradiotherapy assessed by researches
• No obvious active bleeding;
• Adequate hematological, renal and hepatic functions:
• No concomitant malignancies
• Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
• Voluntarily-signed informed consent.

Exclusion criteria

• Concomitant other malignancies;
• Patients with metastatic or recurrent disease;
• Patients received any form of treatment before enrollment;
• Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
• Impaired hematological, renal or hepatic functions:

• Hemoglobin < 9.0 g/dl
• Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L
• Platelets > 100 × 109/L
• Serum ALT/AST > 2.5×UNL
• Serum Total bilirubin > 1.5× UNL

g. Serum urea nitrogen (BUN) > 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) > 1.5 × upper normal limit (UNL)

• Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
• Patients with uncontrolled mental diseases;
• Pregnant or lactating woman;
• Participating in other clinical trials;
• Anyone considered not suitable for enrollment by principal investigator;