Phase 3 Oesophageal Cancer Trial, Recruiting NCT04328948 Sponsor: National Cancer Center, Japan Condition: Oesophageal Cancer
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Phase 3 Oesophageal Cancer Trial, Recruiting

NCT04328948
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People whose cancer has been confirmed by tissue testing to be a specific type of esophageal cancer: squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
  • People whose main cancer lesion is located in the chest portion of the food pipe (esophagus), though some secondary lesions may be in other areas (confirm with trial site).
  • People whose scans (CT with contrast dye) show the cancer has not spread to nearby lymph nodes or other parts of the body.
  • People whose cancer is assessed by internal camera examination (endoscopy) as having grown into a specific depth of the esophagus wall, known as the submucosal layer (cT1b).
  • People aged 20 years or older.
  • People who are generally well enough to carry out daily activities, with minimal or no limitations (ECOG performance score of 0 or 1).
  • People who have not had any prior treatment for esophageal cancer, except for a complete removal of an earlier lesion by endoscopic procedure (EMR/ESD) that met specific pathology criteria (confirm with trial site).
  • People who have not had radiotherapy to the neck, chest, or upper abdomen for any cancer, and have not had chemotherapy or hormone therapy within the past 3 years for any cancer.
  • People whose major organ functions (blood counts, liver, kidney, and oxygen levels) meet the required blood test thresholds (confirm with trial site for specific values).
  • People who, after receiving a full explanation, do not have a strong preference to have surgery as their first treatment.
  • People who are willing and able to provide written consent to participate.

Who may not be able to join:

  • People who have had another cancer at the same time or within the past 5 years, unless it was a very early surface-level cancer treatable with local therapy.
  • People who currently have an active infection that requires treatment with systemic (whole-body) medications.
  • People who have a fever above 38 degrees Celsius.
  • People who are pregnant, have given birth within the past 28 days, or are currently breastfeeding; also, males whose partner is trying to become pregnant.
  • People who have a psychological condition that would make it difficult to participate in the study (confirm with trial site).
  • People who are currently taking ongoing systemic steroid or immune-suppressing medications.
  • People who test positive for Hepatitis B surface antigen or HIV antigen.
  • People with diabetes that cannot be adequately controlled despite ongoing use of insulin or blood sugar-lowering medications.
  • People with high blood pressure that is not adequately controlled.
  • People who have had unstable chest pain (angina) within the past 3 weeks, or a heart attack within the past 6 months.
  • People with serious uncontrolled heart valve disease, a type of enlarged heart (dilated cardiomyopathy), or a thickened heart muscle condition (hypertrophic cardiomyopathy).
  • People whose chest CT scan shows severe emphysema, interstitial pneumonia, or lung scarring (pulmonary fibrosis).
  • People who have had a stroke or related brain blood vessel event within the past 6 months.
  • People who have a known allergy to iodine-based substances (such as contrast dye used in CT scans).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ken Kato, MD/PhD, National Cancer Center Hospital

Phone: 81335422511

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
National Cancer Center, Japan
Registry
ClinicalTrials.gov
Start date
1 July 2020
Est. completion
31 March 2030

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Major progression-free survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov