RecruitingPhase 2NCT06603402

Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC

Low-Dose Involved-Field Radiotherapy Combined with Immunochemotherapy for Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma: a Prospective, Single-Arm, Phase II Study.


Sponsor

Sichuan University

Enrollment

41 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma. The key questions this study seeks to address are: * Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects? * Does this combined approach improve PFS and OS in these patients? Participants in the study will: * Undergo an endoscopy at West China Hospital to confirm their diagnosis. * Receive a treatment regimen that includes low-dose radiotherapy at 45.0 Gy in 1.8 Gy per fraction over 25 fractions, alongside immunochemotherapy, with three cycles of chemotherapy administered every 3 weeks. * After completing the full treatment regimen, participants will undergo regular follow-up visits and monitoring by healthcare professionals.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding low-dose radiation to specific sites, combined with immunotherapy and chemotherapy, can help prevent esophageal squamous cell cancer from returning in patients who have already completed radical (curative-intent) treatment. **You may be eligible if...** - You are between 18 and 80 years old - You have locally advanced esophageal squamous cell carcinoma that was treated with curative-intent chemoradiotherapy (this includes cases involving the cervical esophagus, T4 tumours, certain lymph node involvement, or cancers that couldn't be surgically removed) - Follow-up scans 2–3 weeks after completing radical treatment showed no sign of remaining tumour or spread - You are able to provide a tissue sample from your tumour - Your major organ function is normal and your performance status is 0 or 1 - Patients of childbearing potential must agree to use contraception **You may NOT be eligible if...** - You have a history of fistula (an abnormal opening) from the tumour invading nearby structures - You are at high risk of gastrointestinal bleeding or esophageal perforation - You have poor nutritional status - You experienced serious immune-related side effects (grade 3 or above) during prior treatment - You have interstitial lung disease, autoimmune diseases, or are on immunosuppressant medications - You have another active cancer 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

RADIATIONlow-dose involved-field radiotherapy combined with immunochemotherapy

low-dose involved-field radiotherapy combined with immunochemotherapy


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06603402


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