New treatment approach for T4 esophageal cancer
Official title: A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
Run by National Cheng-Kung University Hospital · NCT06531434 · Data updated 2026-11-12
This study is testing a new treatment plan for people with T4 esophageal cancer to see if combining chemotherapy with radiation can help them feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tainan, Taiwan) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | April 30, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | September 22, 2025 |
| Trial ID | NCT06531434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with histologically confirmed T4-stage esophageal squamous cell carcinoma.
✕Probably not a fit
Patients with previous chemotherapy history or those with other malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates a novel treatment strategy for T4-stage esophageal cancer, focusing on the safety and efficacy of induction chemotherapy followed by chemoradiotherapy. Participants will receive 4 to 8 cycles of induction chemotherapy, and if their condition improves, they will proceed to concurrent chemoradiotherapy. The study aims to reduce the high rate of esophageal perforation and improve treatment response rates and overall survival. Regular clinic visits and symptom diaries will be part of the participant experience to monitor progress and side effects.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce complications for patients with T4 esophageal cancer.
How similar studies have gone: Other studies have explored similar treatment approaches, but this specific strategy is novel and aims to address significant challenges in treating T4 esophageal cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed esophageal squamous cell carcinoma 2. Tumor or lymph nodes invade adjacent organs (T4 stage) 3. Aged between 18-70 years old 4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2 5. 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. Exclusion Criteria: 1. Previous chemotherapy history 2. Myocardial infarction within the last three months 3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema 4. Has other malignancies currently 5. Uncontrolled infection 6. Pregnancy or lactation 7. Perforated esophagus at the time of diagnosis
Where it's running
-
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan Recruiting
Study contacts
- Study coordinator: Wei-Lun Chang, PhD
- Email: weilun1@mail.ncku.edu.tw
- Phone: +886-6-2353535
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.