NCT06952621

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

A Multicenter, Randomized Controlled Clinical Study Comparing Neoadjuvant Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in the Treatment of Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Type	Name	Description
DRUG	3 cycles (Toripalimab + chemotherapy)	Toripalimab: 240mg, intravenous infusion, on Day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Nab-paclitaxel: 125mg/m², intravenous infusion, on Day 1 and Day 8, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Cisplatin: 75mg/m², intravenous infusion, on Day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment;
DRUG	3 cycles（DCF）	Docetaxel: 70mg/m², intravenous infusion, on day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Cisplatin: 70mg/m², intravenous infusion, on day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; 5-FU (5-fluorouracil): 750mg/m², intravenous infusion, on day 1 to day 5, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-28
• Completion: 2028-12-28
• First posted: 2025-05-01
• Last updated: 2026-01-30

Locations

1 site across 1 country: China