About this trial
This study is a randomized, controlled, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of neoadjuvant toripalimab in combination with nab-paclitaxel and platinum versus neoadjuvant docetaxel in combination with cisplatin and 5-fluorouracil (DCF) in the treatment of resectable locally advanced esophageal squamous cell carcinoma
Eligibility criteria
Qualifiers
Voluntarily sign the written informed consent form;
Age 18-75 years, inclusive of 18 and 75 years, both male and female;
Life expectancy of ≥3 months;
Expected to achieve R0 resection;
Disqualifiers
Previous treatment with PD-1/PD-L1 agents or drugs targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.);
Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Active autoimmune disease or suspicion of such, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., with the exception of type 1 diabetes and hypothyroidism controlled with stable-dose replacement therapy, and skin diseases not requiring systemic treatment (e.g., psoriasis, vitiligo);
History of interstitial lung disease ≥ Grade 2;
Trial design
Treatments tested in this trial
- 3 cycles (Toripalimab + chemotherapy)
- 3 cycles(DCF)