Could chemo after surgery keep esophageal cancer at bay?
NCT ID NCT04174079
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This trial investigates whether giving chemotherapy (docetaxel and nedaplatin) after surgery can prevent esophageal cancer from returning. Patients with a certain stage of thoracic esophageal squamous cell carcinoma who had their tumor fully removed are randomly assigned to receive chemotherapy or just be observed. The main goal is to see if the chemo group has a longer period without cancer recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy with docetaxel and nedaplatin
- What this could lead to
- If successful, this could establish a standard adjuvant chemotherapy regimen to reduce cancer recurrence after surgery for esophageal cancer.
- What could go wrong
- This is a single-center trial with 232 participants, and the chemotherapy may cause side effects like low blood counts and nerve damage. The results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 232 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery. 2. T≥3 or N≥1, and more than 15 lymph nodes were dissected. 3. Age ≥18 years and ≤75 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL. 6. Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN. 7. Adequate renal function: serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min. 8. Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent Exclusion Criteria: 1. Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study. 2. Serious postoperative complications that will affect progress of chemotherapy. 3. Patients with chemotherapy contraindications. 4. Women who are pregnant or breast-feeding or who are planning for pregnancy. 5. Unable to complete the follow-up as planned. 6. Without informed consent due to psychological, family, social and other factors.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen Uniersity Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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