RecruitingPhase 3NCT07372300

Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer

The Efficacy of Combination of Modulated Electro-Hyperthermia(mEHT) in The Multimodality Management in Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial.


Sponsor

Shih-Kai Hung

Enrollment

126 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate if the addition of modulated electro-hyperthermia (mEHT) improves tumor down-staging and pathological response in adult patients (20 years and above) with locally advanced rectal adenocarcinoma (cT3N0M0 with high risk of recurrence, cT3N1-2M0, or cT4N0-2M0). The main questions it aims to answer are: * Does the addition of mEHT to the Total Neoadjuvant Therapy (TNT) regimen significantly increase the rate of tumor down-staging (ypT and ypN) compared to TNT alone? * Does the combination therapy improve the pathological complete response (pCR) rate and long-term outcomes (such as disease-free survival) compared to standard TNT? Researchers will compare participants randomized to receive Total Neoadjuvant Therapy (TNT) plus mEHT using the Oncotherm EHY-2030 device to participants receiving TNT alone to see if the adjunctive mEHT therapy enhances tumor regression and improves patient prognosis. Participants will be randomized (1:1) into one of the two groups and will undergo the following regimen: * Receive standard TNT, which includes 5-6 weeks of chemoradiotherapy (CRT) followed by 4-6 months of neoadjuvant chemotherapy. * Patients in the experimental group will receive mEHT twice a week during the CRT period.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding modulated electro-hyperthermia (mEHT) — a treatment that uses gentle heat to target tumors — alongside standard chemoradiation therapy before surgery can improve outcomes for people with locally advanced rectal cancer. **You may be eligible if...** - You are 20 years or older - You have been diagnosed with rectal adenocarcinoma at an advanced stage (T3 with high-risk features, T4, or N1–2) without distant spread - Your cancer requires neoadjuvant (pre-surgery) treatment - You are in good enough physical condition for standard long-course radiation with chemotherapy (ECOG 0–2) - Your expected survival is at least 6 months - You are willing to provide signed consent **You may NOT be eligible if...** - You have an active infection or severe underlying medical conditions - You are unable to tolerate standard radiation and chemotherapy treatment 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

DEVICEHyperthermia

Modulated electro-hyperthermia, 2 times weekly for 6 weeks


Locations(1)

Dalin Tzu Chi Hospital

Chiayi City, Dalin Township, Taiwan

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NCT07372300


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