Phase 1 Oesophageal Cancer Trial, Recruiting NCT04615013 Sponsor: M.D. Anderson Cancer Center Condition: Oesophageal Cancer
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Phase 1 Oesophageal Cancer Trial, Recruiting

NCT04615013
Recruiting Phase 1

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 who have been diagnosed with a confirmed type of cancer called adenocarcinoma, located in the esophagus (food pipe) or at the junction where the esophagus meets the stomach
  • People whose esophageal cancer is classified as stage II or stage III
  • People who are medically fit enough to receive a combined treatment of chemotherapy and radiation therapy, using one of the following chemotherapy combinations: oxaliplatin with 5-FU or capecitabine; docetaxel and/or 5-FU or paclitaxel; or carboplatin with paclitaxel
  • People whose tumor can be reached for a special injection procedure using an ultrasound-guided scope (called an endoscopic ultrasound), as judged by the treating doctor — including some cases where the scope cannot pass all the way through the tumor
  • People who have between 1 and 4 measurable tumors in the esophagus that can be tracked over time using standard imaging scans, with nearby lymph node involvement also allowed under certain size conditions
  • People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities)
  • People whose blood test results meet minimum levels for red blood cells, white blood cells, and platelets (confirm specific thresholds with trial site)
  • People whose kidney function meets the minimum levels required, as measured by blood and urine tests (confirm specific thresholds with trial site)
  • People whose liver function falls within acceptable ranges, as measured by blood tests (confirm specific thresholds with trial site)
  • Women of childbearing potential who have a negative pregnancy test within 7 days before the injection procedure
  • People who have read and signed a consent form confirming they understand the study and are willing to take part

Who may not be able to join:

  • People who have previously received radiation therapy or any other treatment for esophageal cancer
  • People who have previously had surgery to remove an esophageal tumor
  • People whose esophageal cancer has spread to other parts of the body (metastases), as seen on scans at the time of screening
  • People with a past medical history of a hole or abnormal connection involving the esophagus (esophageal fistula or tracheoesophageal fistula), or a specific tumor type called Siewert type III
  • People whose tumor is large or positioned in a way that the treating doctor believes could cause a dangerous connection to form between the esophagus and airway (confirm with trial site)
  • People who have had an active or poorly controlled stomach or esophageal ulcer within 28 days before enrolling
  • People who have a known allergy or medical reason preventing the use of certain contrast dyes used in imaging scans (iodine-based or gadolinium-based)
  • People who have another active cancer, other than esophageal cancer — with exceptions for certain treated skin cancers or low-risk prostate cancer that has been successfully treated and has not returned for at least 3 months
  • People with serious uncontrolled health conditions such as active infection, heart failure, unstable chest pain, kidney failure, irregular heartbeat, or a mental health condition that could affect their ability to follow the study plan
  • People with active, uncontrolled HIV, hepatitis B, or hepatitis C infection
  • Women who are pregnant or currently breastfeeding
  • Women of childbearing potential, and their male partners, who are unwilling or unable to use a highly effective method of contraception throughout the entire study period
  • People for whom the study doctor believes participation would not be in their best interest, or where a condition might interfere with the study assessments

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 7 July 2026
Phase 1: approximately ~10% 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.

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Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
23 November 2020
Est. completion
31 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of dose limiting toxicities (DLTs); Maximum tolerated dose and recommended phase 2 dose (RP2D)

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: 7 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