Actively Recruiting
Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer
Led by Shih-Kai Hung · Updated on 2026-01-28
126
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
S
Shih-Kai Hung
Lead Sponsor
D
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Any gender
- Pathologically confirmed adenocarcinoma of the rectum
- Expected survival of at least six months
- Clinical stages cT3N0 with high recurrence risk, cT3N1-2, or cT4N0-2 without distant metastasis
- ECOG performance status between 0 and 2
- Suitable health condition for long-course radiotherapy and chemotherapy
- Willingness to participate and signed informed consent
You will not qualify if you...
- Active infection or severe underlying disease making treatment unsafe
- Known HIV infection
- Untreated thyroid disease
- Active Crohn's disease or ulcerative colitis
- Other systemic autoimmune diseases
- Physical or mental disorders affecting understanding or compliance
- Known allergy to trial medications
- Pregnant or breastfeeding women
- Substance or alcohol dependence within six months before screening
- Inability to comply with treatment, assessments, or follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dalin Tzu Chi Hospital
Chiayi City, Dalin Township, Taiwan, 600401
Actively Recruiting
Research Team
P
Pei-Yu Hsu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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