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RECRUITING
NCT06637163
PHASE2

Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-10-24

Completion Date

2027-04

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

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

Locations (5)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China