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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorShih-Kai Hung

About this trial

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 criteria

Qualifiers

Age: 20 years and above

Gender: Not restricted

Initial pathological diagnosis of adenocarcinoma of the rectum

Expected survival ≥ six months

Disqualifiers

(e) Active infection or severe underlying disease making the patient unsuitable for the trial treatments

Known HIV infection

Untreated thyroid disease

Active Crohn's disease or ulcerative colitis

Trial design

Treatments tested in this trial

  • Hyperthermia

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shih-Kai Hung

Lead sponsor

Dalin Tzu Chi General Hospital

Sponsor institution

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaborator