RecruitingPhase 2NCT06637163

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

100 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called benmelstobart to chemotherapy and radiation therapy before surgery can improve outcomes in people with resectable (surgically removable) esophageal squamous cell cancer (a cancer of the food pipe). **You may be eligible if...** - You are 18 or older with histologically confirmed esophageal squamous cell cancer - Your cancer is at a resectable stage (T1-3N+M0 or T3NanyM0) - You have not received any prior cancer treatment for your esophageal cancer - Your blood counts, liver, kidney, and heart function meet required levels - You are willing to use contraception during and for 6 months after the study **You may NOT be eligible if...** - You have other active cancers - You have had prior radiation to the chest or esophagus - You have active autoimmune disease or are on immunosuppressive medications - You are pregnant or breastfeeding - You have uncontrolled infections or serious heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBenmelstobart+ 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.)

DRUGPaclitaxel + 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

View Full Details on ClinicalTrials.gov

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NCT06637163


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