Oesophageal Cancer Trial, Recruiting NCT04481256 Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Condition: Oesophageal Cancer
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Oesophageal Cancer Trial, Recruiting

NCT04481256
Recruiting Not Applicable

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 squamous cell carcinoma (a type of cancer) of the esophagus (food pipe) or the area where the esophagus meets the stomach, confirmed by a tissue sample test.
  • People whose cancer cannot be removed by surgery, as determined by scans and imaging tests, or people whose cancer could be surgically removed but who have chosen not to have surgery.
  • People whose cancer has spread only to the lymph nodes just above the collarbone (supraclavicular nodes), with no other distant spread.
  • People whose cancer has come back in the same local area after previous surgery alone, or after removal by endoscope, without spreading to distant parts of the body.
  • People whose cancer has come back in a new area (outside the previously treated area) after prior chemotherapy with radiation plus surgery, or after prior chemotherapy with radiation alone, where a full dose of radiation can still be safely given.
  • People whose tumor extends slightly below the junction of the esophagus and stomach into the upper stomach, as long as the main bulk of the tumor is still in the esophagus or the junction area.
  • People aged 18 or older.
  • People who are reasonably well and able to carry out daily activities, as measured by a standard medical rating scale (ECOG score of 0–2) (confirm with trial site).
  • People whose blood counts, liver function, kidney function, and blood clotting levels meet specific thresholds set by the trial (confirm with trial site for exact values).
  • People who are able and willing to give written informed consent.
  • People who are able to attend all required appointments and follow-up visits at the treatment centre.

Who may not be able to join:

  • People who have, or have had, another cancer that could affect the outlook of their esophageal cancer.
  • People who have a hole or opening between the esophagus and the airway (tracheo-esophageal fistula), or whose tumor has grown through the wall of the airway, or who are considered at high risk of developing such a complication.
  • People who have cancerous lymph nodes at both the collarbone level and a specific abdominal lymph node region (truncus coeliacus) at the same time.
  • People who are pregnant, planning to become pregnant, or currently breastfeeding.
  • People of reproductive age who are not willing to use highly effective contraception during treatment and for 6 months after treatment ends.
  • People who have already received chemotherapy, radiation, or immune checkpoint inhibitor therapy for their current esophageal cancer.
  • People who have received chemotherapy, targeted therapy, or immune checkpoint inhibitor therapy for any other cancer within the past six months.
  • People who have previously had radiation to the chest area in a way that would prevent a full dose of radiation being safely given to the current tumor.
  • People who still have ongoing side effects (above a mild level) from previous cancer treatment, with the exception of mild nerve-related symptoms, hair loss, or skin pigment changes (confirm with trial site).
  • People who currently have an esophageal stent in place.
  • People who have a history of significant bleeding problems, or who have had a major bleeding event in the month before starting the trial treatment.
  • People who are currently taking blood-thinning medications such as direct oral anticoagulants or coumarins.
  • People who have significant heart or blood vessel disease that would make chemotherapy with radiation unsafe.
  • People who have lung scarring (pulmonary fibrosis) or significant impairment of lung function that would make chemotherapy with radiation unsafe.
  • People with a serious underlying health condition that would prevent them from safely receiving the planned treatment, including people who have had allergic reactions to certain drugs containing a substance called cremophor.
  • People whose mental health or cognitive state would prevent them from understanding and giving informed consent.
  • People who are not able to take in enough calories or fluids, even with the help of a dietitian or tube feeding.
  • People who have an active autoimmune disease (where the immune system attacks the body) that has required systemic medical treatment within the past 2 years. People who only take hormone replacement or similar supportive therapies may still be considered eligible (confirm with trial site). People with vitiligo affecting only the skin are eligible.
  • People who have been diagnosed with an immune deficiency condition, or who are taking steroid medications above a certain dose, or other immune-suppressing drugs, within 7 days before the first dose of trial treatment.
  • People diagnosed with HIV, unless their infection has been stable on antiviral treatment for at least 4 weeks, with no signs of drug resistance, a very low viral load, and a sufficient level of immune cells (confirm with trial site for exact values).
  • People with active hepatitis B or C infection. People whose hepatitis B or C is well controlled on antiviral treatment, with virus levels below a detectable threshold, may still be considered eligible (confirm with trial site).
  • People who have interstitial lung disease or active, non-infectious inflammation of the lungs (pneumonitis).
  • People who have an active infection requiring antibiotic or antiviral treatment that has not resolved within a set number of days before starting the trial (confirm with trial site for specific timeframes).
  • People who have received a live vaccine within 30 days before the first dose of trial treatment. (Standard flu vaccines that do not contain a live virus are permitted.)
  • People who have previously had a bone marrow transplant or a solid organ transplant from a donor.

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Hanneke WM van Laarhoven, MD,PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Phone: +31 20 4443312

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
Not Applicable
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Registry
ClinicalTrials.gov
Start date
11 November 2020
Est. completion
1 September 2025

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Feasibility difined as the percentage of patients completing at least two cycles of bintrafusp alfa

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