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NCT06531434RecruitingPhase 1/2

Establishing Best Treatment Strategy for T4 Esophageal Cancer

A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer

Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are: * Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate? * Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer. Participants will: * Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3 * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
22 (estimated)
First submitted
16 Jul 2024
Start date
1 Aug 2024
Primary completion date
30 Apr 2026
Lead sponsor
National Cheng-Kung University Hospital
NCT number
NCT06531434

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 22
  • From 1 Aug 2024 to the primary completion date, 30 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous chemotherapy history

Other illness

  • Myocardial infarction within the last three months
  • History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
  • Has other malignancies currently
  • Uncontrolled infection

Other

  • Pregnancy or lactation
  • Perforated esophagus at the time of diagnosis

Who the study is looking for

  • Histologically confirmed esophageal squamous cell carcinoma
  • Tumor or lymph nodes invade adjacent organs (T4 stage)
  • Aged between 18-70 years old
  • Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2
  • Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10\^3/L, platelet count ≥ 100×10\^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.