Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial
The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.
• The result of pathological biopsy showed esophageal squamous cell carcinoma;
• Have not received systemic or local treatment for esophageal cancer in the past;
• Age 18-75 years (including 18 and 75 years old), both male and female;
• ECOG score 0-1;
• Thoracic esophageal cancer assessed by CT/MRI/PET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;
• Those who are expected to achieve R0 resection;
• Voluntarily sign an informed consent form before treatment;
• Plan to receive surgical treatment after neoadjuvant treatment is completed;
• No surgical contraindications;
⁃ Normal function of major organs
⁃ Female subjects with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last administration Measures (such as intrauterine devices, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last administration;
⁃ The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the plan;