Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in Esophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

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)

Treatment groups

390 Participants
are divided into 2 treatment groups

Sponsors and collaborators