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New treatment option for Esophageal Cancer
Official title A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study
ClinicalTrials.gov ID: NCT06290505
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Also referred to as Imfinzi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Symptomatic dysphagia (Mellow score greater than 0)
- ECOG performance status 0-2
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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...
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Signed, written and informed consent.
- 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...
- 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...
- 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...
- 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.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Garran, Australian Capital Territory, Australia
- Albury, New South Wales, Australia
- Newcastle, New South Wales, Australia
- Herston, Queensland, Australia
- Bedford Park, South Australia, Australia
- Fitzroy, Victoria, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Grafton, Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garran, Australian Capital Territory, Australia; Albury, New South Wales, Australia; Newcastle, New South Wales, Australia; Herston, Queensland, Australia; Bedford Park, South Australia, Australia; Fitzroy, Victoria, Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.