RecruitingPhase 2NCT06446726

Low-dose Radiation Combined With Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Low-dose Radiation Combined With Neoadjuvant Chemotherapy and Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma


Sponsor

Sichuan University

Enrollment

30 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to investigate the efficacy and safety of low-dose radiation combined with neoadjuvant chemotherapy and immunotherapy in the treatment of locally advanced thoracic esophageal squamous cell carcinoma. By reducing the radiation dose from 40 Gy in 20 fractions to 4 Gy in 2 fractions, the goal is to lessen the adverse reactions caused by radiotherapy. Additionally, the study explores whether low-dose radiation therapy can promote the cross-presentation of tumor-specific antigens and increase lymphocyte infiltration into the tumor site. Study also examines whether this approach can enhance tumor-specific immune responses, thereby potentially improving the efficacy of immune checkpoint inhibitors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a low dose of targeted radiation before surgery to a standard treatment regimen (immunotherapy plus chemotherapy) — called neoadjuvant treatment — improves outcomes for patients with esophageal squamous cell carcinoma that is planned for surgical removal. **You may be eligible if...** - You are between 18 and 75 years old with confirmed thoracic esophageal squamous cell carcinoma - Your cancer is staged as potentially curable with surgery (clinical stages cT1b-T4a, N0-2, M0) - You are in good health (ECOG 0–1) with adequate lung, heart, blood, liver, and kidney function - You are willing to undergo surgery, chemotherapy, radiation, and immunotherapy as part of the study **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have significant breathing or heart problems that prevent surgery - You are pregnant or breastfeeding - You have a perforated esophagus or active bleeding 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

DRUGTislelizumab

Patients will undergo two cycles of immunotherapy, each cycle lasting 21 days. Day 3 and Day 24: Tislelizumab, fixed dose of 200 mg

RADIATIONLow-dose radiotherapy

Patients will undergo two cycles of low-dose radiotherapy. Day 1/2 and Day 22/23: Low-dose radiotherapy (8 Gy/4f)

DRUGNab-paclitaxel

Patients will undergo two cycles of chemotherapy. Day 3 and Day 24: Nab-paclitaxel 260 mg/m2

DRUGCisplatin

Patients will undergo two cycles of chemotherapy. Day 3 and Day 24: Cisplatin 75 mg/m2.


Locations(1)

Sichuan University West China Hospital

Chengdu, Sichuan, China

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NCT06446726


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