New combo therapy aims to ease swallowing in advanced esophageal cancer
NCT ID NCT06290505
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing whether adding a targeted radiation dose and the immunotherapy drug durvalumab to standard chemotherapy and radiation can help people with advanced esophageal cancer who have trouble swallowing. The study will enroll 54 adults whose cancer has spread to a few other spots or is too advanced for surgery. The main goal is to see if this approach can keep the cancer from growing and improve swallowing symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Durvalumab (Imfinzi) plus chemotherapy and radiation
- What this could lead to
- If successful, this could offer a new treatment option that helps people with advanced esophageal cancer swallow more easily and live longer without their cancer getting worse.
- What could go wrong
- This is a small, early-phase trial with only 54 people, so results may not apply to everyone. Adding immunotherapy and extra radiation can cause serious side effects, and the cancer may still progress.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
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 years and older
- 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. Males and females \> 18 years of age. 2. Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-oesophageal junction 3. Oligometastatic disease (1-5 lesions outside the primary tumour radiotherapy field on FDG-PET scan), or locoregionally advanced disease unsuitable for either surgical resection or radical chemoradiotherapy 4. Symptomatic dysphagia (Mellow score greater than 0) 5. ECOG performance status 0-2 6. Anticipated life expectancy of greater than 12 weeks. 7. Body weight of greater than 30kg. 8. Adequate bone marrow function, with values within the ranges specified below. Blood transfusions are permissible. 1. White blood cell count greater than or equal to 2 x (10 to the power of 9)/L 2. Absolute neutrophil count greater than or equal to 1.5 x (10 to the power of 9)/L 3. Platelets greater than or equal to 100 x (10 to the power of 9)/L 4. Haemoglobin greater than or equal to 90g/L 9. Adequate liver function, with values within the ranges specified below: 1. Alanine transferase less than or equal to 2.5 x upper limit of normal (ULN) 2. Aspartate transferase less than or equal to 2.5 x ULN 3. Total bilirubin less than or equal to 1.5 x ULN (except patients with Gilbert's Syndrome, who can have total bilirubin less than or equal to 5 x ULN) 10. Adequate renal function, with values within the ranges specified below. Note that an estimated renal function of greater than 125mL/min by the Cockroft-Gault formula must not be used for carboplatin dosing, and must instead be determined using a direct method. 1. Serum creatinine less than or equal to 1.5 x ULN 2. Creatinine clearance (CrCl) greater than or equal to 40 mL/min using Cockroft-Gault formula 11. Tumour tissue (formalin-fixed, paraffin embedded) should be available for PD-L1 and mismatch repair (MMR) protein expression and can be provided as a block or slides (archival tissue is acceptable). Blocks prepared from cytological samples, where tumour cell number is sufficient, are also acceptable. Patients will not be selected by PD-L1 or MMR status. 12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 13. Signed, written and informed consent. Exclusion Criteria: 1. Bulky or organ-threatening metastatic disease requiring upfront higher dose chemotherapy in the judgement of the treating clinician. 2. Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation) if oligometastatic disease. 3. Previous systemic therapy for oesophageal or GOJ carcinoma. 4. Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases is permitted. 5. Esophageal stent in situ. 6. Known tracheo-oesophageal fistula. 7. Known leptomeningeal or brain metastases. 8. Major surgical procedure (as defined by the Investigator) within 28 days prior to first day of study treatment. Note: Local surgery of isolated lesions for palliative intent is permitted. 9. History of another malignancy within the last 3 years, with the exception of adequately treated non-melanomatous skin cancer, carcinoma in situ and superficial transitional cell carcinoma of the bladder. 10. Prior therapy with an anti-PD1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways. 11. Sensory neuropathy of grade 2 or higher severity per CTCAE v5.0. 12. History of allergy or hypersensitivity to study drug components, or other contraindications to any of the study drugs. Active or prior documented autoimmune disorders (including inflammatory bowel disease \[e.g., ulcerative colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc). Patients with the following conditions are exceptions to this criterion: 1. Vitiligo or alopecia. 2. Hypothyroidism (e.g., following Hashimoto syndrome) stable on thyroid hormone replacement. 3. Any chronic skin condition (e.g. psoriasis) that does not require systemic therapy. 4. Type 1 diabetes mellitus. 5. Coeliac disease controlled by diet alone. Patients without active autoimmune disease in the last 5 years may also be included but only after consultation with the Chief Principal Investigators. 13. Any condition requiring continuous systemic treatment with either regular corticosteroids (\>10mg daily prednisone or equivalent dose of an alternative corticosteroid) or other immunosuppressive medications within 14 days of study drug administration. Intranasal, inhaled or topical steroids, and adrenal replacement steroid doses \>10mg daily oral prednisone equivalent, are permitted in the absence of active autoimmune disease. 14. Positive test for hepatitis B surface antigen (HBsAg) indicating acute or chronic infection. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. 15. Positive test for hepatitis C virus antibody (HCV antibody) , unless polymerase chain reaction is negative for HCV RNA. 16. History of other significant, or active, infection, including HIV or tuberculosis (TB). HIV testing is not mandatory unless clinically indicated. Clinical evaluation for active TB may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice. 17. Receipt of a transplanted solid organ (kidney, liver, heart or lung) or of an allogeneic bone marrow transplant. 18. Receipt of a live attenuated vaccine within 30 days prior to registration. 19. Use of alternative or traditional medicines within 14 days prior to registration. 20. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the patient to give written informed consent. 21. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception to avoid pregnancy for 90 days after the last dose of durvalumab. Women of childbearing potential must have a negative pregnancy test within 24 hours prior to trial registration. Men must have been surgically sterilized or use a double barrier method of contraception if they are sexually active with a woman of childbearing potential for a period of 180 days after the last dose of durvalumab and chemotherapy, or 90 days after the last dose of durvalumab monotherapy (whichever is the longer time period). Sperm donation is not permitted for 180 days after the last dose of durvalumab and chemotherapy, or 90 days after the last dose of durvalumab monotherapy (whichever is the longer time period).
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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
8 sites in 2 countries. 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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Auckland Hospital
RECRUITINGGrafton, Auckland, 1023, New Zealand
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Border Medical Oncology
ACTIVE_NOT_RECRUITINGAlbury, New South Wales, 2640, Australia
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Calvary Mater Newcastle
RECRUITINGNewcastle, New South Wales, 2298, Australia
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Canberra Hospital
RECRUITINGGarran, Australian Capital Territory, 2605, Australia
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Flinders Medical Centre
RECRUITINGBedford Park, South Australia, Australia
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, Victoria, 3000, Australia
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Royal Brisbane and Women's Hospital
RECRUITINGHerston, Queensland, 4029, Australia
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Sir Charles Gairdner Hospital
RECRUITINGNedlands, Western Australia, 6009, Australia
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St Vincent's Hospital
RECRUITINGFitzroy, Victoria, 3065, Australia
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Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink tumors that resist standard care?