Establishing Best Treatment Strategy for T4 Esophageal Cancer
Recruiting
Phase 1Phase 2Interventional Study
Esophageal Cancer TNM Staging Primary Tumor (T) T4
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
22 (estimated)
Sponsor
National Cheng-Kung University Hospital · Other
Who this trial is looking for
This trial is looking for people with advanced esophageal cancer to test a new treatment approach. Participants will receive chemotherapy for several weeks, followed by additional treatment, and will visit the clinic weekly for checkups.
Are You a Good Fit for This Trial?
You may be able to join if
I have esophageal squamous cell carcinoma.
My cancer has spread to nearby organs.
I am between 18 and 70 years old.
I am in good health with an ECOG performance status less than 2.
My blood tests show I have enough hemoglobin and white blood cells.
I have normal levels of bilirubin and liver enzymes.
My kidneys are working well with a clearance of at least 40 mL/min.
You may not be able to join if
I have had chemotherapy before.
I had a heart attack in the last three months.
I have a history of unstable angina or serious lung disease.
I currently have another type of cancer.
I have an uncontrolled infection.
I am pregnant or breastfeeding.
My esophagus is perforated at diagnosis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 chemoradi…
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
Trial Locations
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Status
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, a…
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
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