NCT06637163

Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC

A Randomized Controlled, Multicenter Clinical Study of Benmelstobart Combined With Radiochemotherapy Versus Radiochemotherapy as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will explore the efficacy and safety of benmelstobart combined with radiochemotherapy compared to radiochemotherapy alone as neoadjuvant treatment for esophageal squamous cell carcinoma. It will also compare the effectiveness and safety of low-dose radiotherapy versus standard-dose radiotherapy in neoadjuvant regimens that include benmelstobart with concurrent radiochemotherapy. This research may provide more treatment options for patients with esophageal squamous cell carcinoma.

Detailed description

Eligible participants will be randomly assigned in a 1:1 ratio to either the benmelstobart plus radiochemotherapy group or the radiochemotherapy group. Surgery will be performed 6-8 weeks after the completion of neoadjuvant treatment, with the primary endpoint being the rate of pathological complete response (pCR).

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy	Benmelstobart: 1200 mg, i.v.gtt , d1, 22; Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week(If the number of patients achieving pCR in this group is ≥ 18 with the first 30 patients enrolled, the subsequent 20 patients will receive a reduced dose of 36 Gy in 20 fractions, 5 days per week.)
DRUG	Paclitaxel + Carboplatin + Radiotherapy	Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-10-15
• Last updated: 2025-04-17

Locations

5 sites across 1 country: China