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Locally Advanced Rectal CarcinomaPhase 3mEHTNCT07372300

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

A Phase 3 study testing Hyperthermia in people with Locally Advanced Rectal Carcinoma, run by Shih-Kai Hung at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Locally Advanced Rectal Carcinoma
What is being tested?
Hyperthermia
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteTaiwan
Study dates
23 Sep 2025to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.
  • 7. 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.

Who cannot join

  • (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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pei-Yu Hsu, Master contact

+886+5+2648000 ext. 5668

dorishsu1071013@gmail.com

Taiwan1 site, 1 recruiting

  • Dalin Tzu Chi Hospital

    Chiayi City, Dalin Township, 600401

    Pei-Yu Hsu Research Assistant, Master's degree, +886+5+2648000 ext. 5668, dorishsu1071013@gmail.com

    Shih Kai Hung, Doctor's degree

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

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?
Read more

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.
Read the detailed description

This study is designed as a pivotal Phase 3, open-label, two-treatment group, multi-institute randomized control trial (1:1).

Study Population \& Allocation:

Participants with pathologically confirmed rectal adenocarcinoma who are recommended for TNT by a specialist surgeon will be included. Patients are randomly allocated (1:1) into either the Experimental Arm (TNT + mEHT combination) or the Control Arm (TNT alone).

Intervention and Device:

Modulated electro-hyperthermia (mEHT, trade name Oncotherm) will be delivered using the Oncotherm EHY-2030 device. This technique uses electromagnetic waves at 13.56 MHz and incorporates a low-frequency current wave to deliver energy selectively to the cancerous area. The Oncotherm computer system automatically adjusts the optimal frequency, introducing random resonance to heat the tumor tissue and improve the tumor microenvironment. Local hyperthermia is intended to control tumors by raising the local body temperature to 39℃-42℃.

We hypothesized that the combination of hyperthermia with other treatments (such as radiotherapy and chemotherapy) can improve treatment outcome without additional toxicity. Patients in the Experimental Arm will receive mEHT twice a week specifically during the CRT period.

Being tested
Hyperthermia
Keywords
Rectal cancer, Hyperthermia, Neoadjuvant, Radiotherapy, Downstaging
Medical subject headings
Rectal Neoplasms, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HyperthermiaDevice

    Modulated electro-hyperthermia, 2 times weekly for 6 weeks

Study groups in NCT07372300
Study groupRoleWhat they receive
TNT + mEHTExperimentalParticipants receive standard TNT with modulated electro-hyperthermia (mEHT). This includes long-course CRT with concurrent mEHT, twice weekly, for 5-6 weeks, followed by neoadjuvant chemotherapy (4-6 months), and finally surgery. Chemoradiation therapy phase Drug: Capecitabine or Tegafur/ Uracil or Fluorouracil (5-FU) + Leucrorin (LV) concomitant with RT Procedure: Radiotherapy Total radiation dose of 45-50.4 Gy delivered in 25-28 fractions to the pelvis, and the dose of 52-56 Gy for gross tumor volumes and positive lymph nodes. Device: Oncotherm Modulated EHY-2030 Oncotherm device is working on a radiofrequency of 13.56 MHz. Treatments are administered twice weekly during the 5-6-week CRT phase. Each session lasts 60 minutes Neoadjuvant systemic therapy: 4-6 months of neoadjuvant chemotherapy using CAPEOX or mFOLFOX 6 regimens following CRT Surgery: Total mesorectal excision (TME) performed after the completion of neoadjuvant chemotherapy.
Receives: Device: Hyperthermia
TNT aloneNo interventionParticipants receive standard TNT without modulated electro-hyperthermia (mEHT). This includes long-course CRT with concurrent mEHT, twice weekly, for 5-6 weeks, followed by neoadjuvant chemotherapy (4-6 months), and finally surgery. Chemoradiation therapy phase Drug: Capecitabine or Tegafur/ Uracil or Fluorouracil (5-FU) + Leucrorin (LV) concomitant with RT Procedure: Radiotherapy Total radiation dose of 45-50.4 Gy delivered in 25-28 fractions to the pelvis, and the dose of 52-56 Gy for gross tumor volumes and positive lymph nodes. Device: Oncotherm Modulated EHY-2030 Neoadjuvant systemic therapy: 4-6 months of neoadjuvant chemotherapy using CAPEOX or mFOLFOX 6 regimens following CRT Surgery: Total mesorectal excision (TME) performed after the completion of neoadjuvant chemotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Down-staging Rate

    Evaluation of the decrease in ypT and ypN staging for patients with locally advanced rectal cancer following the current recommended treatment method, total neoadjuvant therapy (TNT). The ycT and ycN staging will be assessed using MRI within three months post-treatment for patients who do not undergo surgery.

    Measured: Time Frame: 9 months from the date of randomization

Secondary outcomes (18)

  1. Pathological Complete Response (pCR) Rate.

    A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:

    • No evidence of malignant cells in the primary tumor specimen AND
    • No evidence of malignant cells in the lymph nodes.

    Measured: 9 months from the date of randomization

  2. Treatment Response Patterns

    Using the Dworak Scale, defined as "good tumor shrinkage" with Grade 3 and Grade 4.

    Measured: 9 months

  3. Overall Survival (OS)

    OS is defined as time from randomization to the date of death due to any cause.

    Measured: 12, 36, 60 months from the date of randomization

  4. Disease-Free Survival (DFS)

    DFS is defined as the time from randomization to the date of local recurrence, regional recurrence, distant recurrence or death due to all causes whichever comes first. Patients who fail to return for evaluation after beginning therapy will be censored for DFS on the last day of therapy.

    Measured: 12, 36, 60 months from the date of randomization

  5. Local Control Rate (LCR)

    LCR is defined as the time from randomization to the date of the first documentation of local recurrence.

    Measured: Time Frame: 12, 36, 60 months from the date of randomization.

  6. Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization to the date of the first documentation of distant metastasis.

    Measured: 12, 36, 60 months from the date of randomization

  7. Colostomy-Free Survival (CFS)

    CFS is defined as being alive without a colostomy, excluding colostomies reversed during follow-up.

    Measured: 12, 36, 60 months from the date of randomization.

  8. Comparison of Surgery Rates

    Comparison of Surgery Rates is defined as the rate of patients who receive TME between two groups after TNT.

    Measured: 12 months

  9. Surgical Techniques

    Surgical Techniques to be recorded: Total Mesorectal Excision (TME), local excision or other (specify).

    Measured: 12 months

  10. Number of Hyperhermia

    For the optimal treatment, patients in experimental arm receive hyperthermia by using Oncotherm EHY-2030 device, with a planned power output of 60 minutes. The number of treatment where this optimal output could not be reached must be recorded and reported.

    Measured: 9 months

  11. Adverse Effects Assessment

    Using CTCAE v5.0, scored 0 - 5, with higher scores indicating more severe adverse effects. The items include: radiation dermatitis, anorexia, nausea, vomiting, constipation, diarrhea, dysuria, hematuria, and fatigue. All items are planned to be evaluated at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).

    Measured: 2, 36, 60 months

  12. The effect of treatment on white blood cell count

    Recording total white cell counts, absolute neutrophil counts, and absolute lymphocyte counts of all patients. Blood samples are obtained at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).

    Measured: 2, 36, 60 months

  13. The effect of treatment on hemoglobin level

    Recording hemoglobin levels of all patients. Blood samples are obtained at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).

    Measured: 2, 36, 60 months

  14. The effect of treatment on platelet count

    Recording platelet counts of all patients. Blood samples are obtained at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).

    Measured: 2, 36, 60 months

  15. Late Radiation Therapy Adverse Effects

    Using the LENT/SOMA scoring system, evaluating symptoms such as tenesmus, mucosal loss, sphincter control, stool frequency, pain, bleeding, ulceration, stricture, etc., scored 1 - 4, with higher scores indicating worse outcomes.

    Measured: 36, 60 months

  16. Quality of Life Analysis

    Quality of Life (QoL) assessment is mandatory for all eligible patients randomized into the trial. QoL will be evaluated using the total score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A printed questionnaire will be administered in the clinic by a CRA or study nurse at the following time points:

    • Baseline (at the time of randomization, prior to treatment initiation).
    • The last week of neoadjuvant CRT with or without mEHT.
    • Nine months after the completion of the TNT course (approximately 42 weeks ± 3 weeks post-randomization).

    Measured: 12 months.

  17. Rectal Cancer Quality of Life Analysis

    Rectal Cancer Quality of Life (QoL) assessment is mandatory for all eligible patients randomized into the trial. QoL will be evaluated using the total score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29). A printed questionnaire will be administered in the clinic by a CRA or study nurse at the following time points:

    • Baseline (at the time of randomization, prior to treatment initiation).
    • The last week of neoadjuvant CRT with or without mEHT.
    • Nine months after the completion of the TNT course (approximately 42 weeks ± 3 weeks post-randomization).

    Measured: 12 months.

  18. Functional Assessment Post Rectal Cancer Surgery

    Using the LAR score.

    The QoL evaluation focus on functional outcome will be evaluated using LAR score. This assessment is mandatory for all eligible patients randomized into the trial. A printed questionnaire will be administered in the clinic by a CRA or study nurse at the following time points:

    • Baseline (at the time of randomization, prior to treatment initiation).
    • The last week of neoadjuvant CRT with or without mEHT.
    • Nine months after the completion of the TNT course (approximately 42 weeks ± 3 weeks post-randomization).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start23 Sep 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07372300
Sponsor's protocol ID
iIRB No. A11304001
Other IDs
iIRB No. A11304001
Acronym
mEHT
Status last verified
Jan 2026
First submitted
8 Jan 2026
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia-Aguilar J, Patil S, Gollub MJ, Kim JK, Yuval JB, Thompson HM, Verheij FS, Omer DM, Lee M, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Paty PB, Weiser MR, Nash GM, Pappou E, Guillem JG, Temple L, Wei IH, Widmar M, Lin S, Segal NH, Cercek A, Yaeger R, Smith JJ, Goodman KA, Wu AJ, Saltz LB. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. J Clin Oncol. 2022 Aug 10;40(23):2546-2556. doi: 10.1200/JCO.22.00032. Epub 2022 Apr 28.

    PubMed 35483010

  • Park JH, Yoon SM, Yu CS, Kim JH, Kim TW, Kim JC. Randomized phase 3 trial comparing preoperative and postoperative chemoradiotherapy with capecitabine for locally advanced rectal cancer. Cancer. 2011 Aug 15;117(16):3703-12. doi: 10.1002/cncr.25943. Epub 2011 Feb 15.

    PubMed 21328328

  • Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.

    PubMed 22504191

  • Shen MH, Chen LP, Ho TF, Shih YY, Huang CS, Chie WC, Huang CC. Validation of the Taiwan Chinese version of the EORTC QLQ-CR29 to assess quality of life in colorectal cancer patients. BMC Cancer. 2018 Apr 2;18(1):353. doi: 10.1186/s12885-018-4312-y.

    PubMed 29606101

  • Rubin P, Constine LS, Fajardo LF, Phillips TL, Wasserman TH. RTOG Late Effects Working Group. Overview. Late Effects of Normal Tissues (LENT) scoring system. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1041-2. doi: 10.1016/0360-3016(95)00057-6. No abstract available.

    PubMed 7713774

  • Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis. 1997;12(1):19-23. doi: 10.1007/s003840050072.

    PubMed 9112145

  • De Haas-Kock DF, Buijsen J, Pijls-Johannesma M, Lutgens L, Lammering G, van Mastrigt GA, De Ruysscher DK, Lambin P, van der Zee J. Concomitant hyperthermia and radiation therapy for treating locally advanced rectal cancer. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD006269. doi: 10.1002/14651858.CD006269.pub2.

    PubMed 19588384

  • Liu S, Jiang T, Xiao L, Yang S, Liu Q, Gao Y, Chen G, Xiao W. Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis. Oncologist. 2021 Sep;26(9):e1555-e1566. doi: 10.1002/onco.13824. Epub 2021 Jun 7.

    PubMed 33987952

  • Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.

    PubMed 33862000

  • Jin J, Tang Y, Hu C, Jiang LM, Jiang J, Li N, Liu WY, Chen SL, Li S, Lu NN, Cai Y, Li YH, Zhu Y, Cheng GH, Zhang HY, Wang X, Zhu SY, Wang J, Li GF, Yang JL, Zhang K, Chi Y, Yang L, Zhou HT, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Wang WL, Liu SX, Gao YH, Li YX. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 May 20;40(15):1681-1692. doi: 10.1200/JCO.21.01667. Epub 2022 Mar 9.

    PubMed 35263150

  • Dijkstra EA, Nilsson PJ, Hospers GAP, Bahadoer RR, Meershoek-Klein Kranenbarg E, Roodvoets AGH, Putter H, Berglund A, Cervantes A, Crolla RMPH, Hendriks MP, Capdevila J, Edhemovic I, Marijnen CAM, van de Velde CJH, Glimelius B, van Etten B; Collaborative Investigators. Locoregional Failure During and After Short-course Radiotherapy Followed by Chemotherapy and Surgery Compared With Long-course Chemoradiotherapy and Surgery: A 5-Year Follow-up of the RAPIDO Trial. Ann Surg. 2023 Oct 1;278(4):e766-e772. doi: 10.1097/SLA.0000000000005799. Epub 2023 Jan 20.

    PubMed 36661037

  • Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.

    PubMed 33301740

  • Dewdney A, Cunningham D, Tabernero J, Capdevila J, Glimelius B, Cervantes A, Tait D, Brown G, Wotherspoon A, Gonzalez de Castro D, Chua YJ, Wong R, Barbachano Y, Oates J, Chau I. Multicenter randomized phase II clinical trial comparing neoadjuvant oxaliplatin, capecitabine, and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high-risk rectal cancer (EXPERT-C). J Clin Oncol. 2012 May 10;30(14):1620-7. doi: 10.1200/JCO.2011.39.6036. Epub 2012 Apr 2.

    PubMed 22473163

  • Ma B, Gao P, Wang H, Xu Q, Song Y, Huang X, Sun J, Zhao J, Luo J, Sun Y, Wang Z. What has preoperative radio(chemo)therapy brought to localized rectal cancer patients in terms of perioperative and long-term outcomes over the past decades? A systematic review and meta-analysis based on 41,121 patients. Int J Cancer. 2017 Sep 1;141(5):1052-1065. doi: 10.1002/ijc.30805. Epub 2017 Jun 8.

    PubMed 28560805

  • Roh MS, Colangelo LH, O'Connell MJ, Yothers G, Deutsch M, Allegra CJ, Kahlenberg MS, Baez-Diaz L, Ursiny CS, Petrelli NJ, Wolmark N. Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03. J Clin Oncol. 2009 Nov 1;27(31):5124-30. doi: 10.1200/JCO.2009.22.0467. Epub 2009 Sep 21.

    PubMed 19770376

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hyperthermia in people with Locally Advanced Rectal Carcinoma, run by Shih-Kai Hung at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pei-Yu Hsu, Master (+886+5+2648000 ext. 5668, dorishsu1071013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Down-staging Rate (time frame: Time Frame: 9 months from the date of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07372300, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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