A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study

Recruiting now · Phase 2

Conditions studied: Esophageal Cancer

In brief

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with esophageal cancer that is locally advanced or has spread to another area of the body (metastasized).

Key facts

Study ID

NCT06290505

Run by

Australasian Gastro-Intestinal Trials Group

People needed

54

Starts

2021-12-08

Expected to finish

2029-07-31

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females > 18 years of age.
• Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-oesophageal junction
• 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
• Symptomatic dysphagia (Mellow score greater than 0)
• ECOG performance status 0-2
• Anticipated life expectancy of greater than 12 weeks.
• Body weight of greater than 30kg.
• Adequate bone marrow function, with values within the ranges specified below. Blood transfusions are permissible.
• White blood cell count greater than or equal to 2 x (10 to the power of 9)/L
• Absolute neutrophil count greater than or equal to 1.5 x (10 to the power of 9)/L
• Platelets greater than or equal to 100 x (10 to the power of 9)/L
• Haemoglobin greater than or equal to 90g/L
• Adequate liver function, with values within the ranges specified below:
• Alanine transferase less than or equal to 2.5 x upper limit of normal (ULN)
• Aspartate transferase less than or equal to 2.5 x ULN
• 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)
• 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.
• Serum creatinine less than or equal to 1.5 x ULN
• Creatinine clearance (CrCl) greater than or equal to 40 mL/min using Cockroft-Gault formula
• 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.
• Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
• Signed, written and informed consent.

You may not qualify if…

• Bulky or organ-threatening metastatic disease requiring upfront higher dose chemotherapy in the judgement of the treating clinician.
• Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation) if oligometastatic disease.
• Previous systemic therapy for oesophageal or GOJ carcinoma.
• Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases is permitted.
• Esophageal stent in situ.
• Known tracheo-oesophageal fistula.
• Known leptomeningeal or brain metastases.
• 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.
• 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.
• 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.
• Sensory neuropathy of grade 2 or higher severity per CTCAE v5.0.
• 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:
• Vitiligo or alopecia.
• Hypothyroidism (e.g., following Hashimoto syndrome) stable on thyroid hormone replacement.
• Any chronic skin condition (e.g. psoriasis) that does not require systemic therapy.
• Type 1 diabetes mellitus.
• 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.
• 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.
• 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.
• Positive test for hepatitis C virus antibody (HCV antibody) , unless polymerase chain reaction is negative for HCV RNA.
• 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.
• Receipt of a transplanted solid organ (kidney, liver, heart or lung) or of an allogeneic bone marrow transplant.
• Receipt of a live attenuated vaccine within 30 days prior to registration.
• Use of alternative or traditional medicines within 14 days prior to registration.

Where it is running

• Auckland Hospital — Grafton, Auckland, New Zealand (enrolling)
• Canberra Hospital — Garran, Australian Capital Territory, Australia (enrolling)
• Calvary Mater Newcastle — Newcastle, New South Wales, Australia (enrolling)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (enrolling)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
• St Vincent's Hospital — Fitzroy, Victoria, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (enrolling)
• Border Medical Oncology — Albury, New South Wales, Australia

Full record on ClinicalTrials.gov

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