NCT06531434 Establishing Best Treatment Strategy for T4 Esophageal Cancer
| NCT ID | NCT06531434 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Esophageal Cancer TNM Staging Primary Tumor (T) T4 |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2024-08-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06531434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Esophageal Cancer TNM Staging Primary Tumor (T) T4. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06531434 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06531434 currently recruiting?
Yes, NCT06531434 is actively recruiting participants. Contact the research team at weilun1@mail.ncku.edu.tw for enrollment information.
Where is the NCT06531434 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT06531434 clinical trial?
NCT06531434 is sponsored by National Cheng-Kung University Hospital. The trial plans to enroll 22 participants.
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