RecruitingPhase 2NCT06843889

A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

34 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Esophageal Squamous Cell Carcinoma

Summary

This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called toripalimab to the standard combination of chemotherapy and radiation therapy before surgery can improve outcomes for people with esophageal squamous cell carcinoma (a type of throat/esophagus cancer). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is at a stage that can potentially be removed by surgery - You have not received any prior cancer treatment - You are in good general health (able to carry out daily activities) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have a history of esophageal perforation or serious bleeding - You have severe heart, lung, or other organ problems - You are pregnant or breastfeeding 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

DRUGToripalimab (240mg day1, Q3W*3cycle)

Phase 1: Toripalimab (240mg day1, Q3W\*2cycle) + investigator's choice of clinical conventional chemotherapy; Phase 2: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion.

Locations(1)

Nanfang Hospital, Southern Medical University

Guangzhou, Baiyun District, China

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NCT06843889

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