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

Recruiting now · Phase 3

Conditions studied: Locally Advanced Rectal Carcinoma

In brief

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.

Key facts

Study ID: NCT07372300
Run by: Shih-Kai Hung
People needed: 126
Starts: 2025-09-23
Expected to finish: 2027-12-31
Last updated by the study team: 2026-01-28

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age: 20 years and above
Gender: Not restricted
Initial pathological diagnosis of adenocarcinoma of the rectum
Expected survival ≥ six months
Clinical staging of cT3N0 with high recurrence risk or cT3N1-2 or cT4N0-2 rectal cancer, requiring neoadjuvant therapy, without distant metastasis; must meet the following tumor definitions [staging system according to the 8th edition of the AJCC staging manual]:
cT3: Tumor invades through the muscularis propria into pericolorectal tissues
cT4a: Tumor invades through the visceral peritoneum (including gross perforation of the bowel through tumor and continuous invasion of tumor through areas of inflammation to the surface of the visceral peritoneum)
cT4b: Tumor directly invades or adheres to adjacent organs or structures *High recurrence risk factors: cT3 tumor ≤ 5 cm from the anal verge or MRI showing circumferential resection margin (CRM) < 0.2 cm; cT4 tumor or cN2, presence of MRI showing extramural vascular invasion.
ECOG performance status: 0 - 2 8. Healthy condition suitable for standard treatment, including 25 to 30 fractions of long-course radiotherapy and concurrent chemotherapy (capecitabine or fluorouracil) and subsequent 4- to 6-month chemotherapy, including modified FOLFOX-6 or CAPEOX 9. Willingness to participate in the clinical trial and signed the informed consent form for the protocol.

You may not qualify if…

(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
Other systemic autoimmune diseases 9. History of any physical or mental disorder resulting the patient unable to understand or comply with trial requirements, or diminished social communication ability, or unable to provide informed consent 10. Known allergic reaction to trial medications 11. Pregnant or breastfeeding women 12. Substance or alcohol dependence within six months before screening 13. Inability to comply with treatment, assessments, or follow-up

Where it is running

Dalin Tzu Chi Hospital — Chiayi City, Dalin Township, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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