Could chemoradiotherapy replace surgery for esophageal cancer?
NCT ID NCT07629817
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether patients with esophageal cancer who respond well to initial drug therapy can safely avoid surgery and instead receive chemoradiotherapy to preserve their esophagus. Over 1,000 participants will be randomly assigned to either surgery or organ preservation. The goal is to see if the non-surgical approach offers similar cancer control and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab, Nab-paclitaxel, Platinum-based Chemotherapy, Radiation
- What this could lead to
- If successful, this could show that many patients with esophageal cancer can avoid major surgery and keep their esophagus, with similar cancer control outcomes.
- What could go wrong
- This is a large Phase 3 trial, but it's still early to know if organ preservation is as effective as surgery. There is a risk of cancer recurrence or side effects from chemoradiotherapy.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,044 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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. Age 18-75 years, any sex. 2. ECOG Performance Status 0-1. 3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC). 4. Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment. 5. Adequate bone marrow, hepatic, and renal function: * Absolute neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L. * Alanine aminotransferase / Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal. * Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL/min. 6. Signed written informed consent form (ICF). Exclusion Criteria: 1. History of other malignancy within the past 5 years. 2. Active autoimmune disease. 3. Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection. 4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \< 50%, Forced Expiratory Volume in 1 second \< 1 L). 5. Pregnancy or lactation.
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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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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, 450008, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?
- Can a Triple-Drug combo wipe out esophageal tumors before surgery?
- Dye-Guided surgery may spare healthy lymph nodes in esophageal cancer