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OncoMatch/Clinical Trials/NCT06290505

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

Is NCT06290505 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Durvalumab for esophageal cancer.

Phase 2RecruitingAustralasian Gastro-Intestinal Trials GroupNCT06290505Data as of Jun 2026Location: Australia · New Zealand

Treatment: DurvalumabThe 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).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Durvalumab

Cancer type

Esophageal Carcinoma

Biomarker criteria

Excluded: HER2 (ERBB2) positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation)

Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation) if oligometastatic disease

Allowed: PD-L1 (CD274) expression

Tumour tissue ... should be available for PD-L1 and mismatch repair (MMR) protein expression ... Patients will not be selected by PD-L1 or MMR status.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Previous systemic therapy for oesophageal or GOJ carcinoma

Cannot have received: thoracic radiotherapy

Exception: Prior palliative radiotherapy to bony metastases is permitted

Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases is permitted.

Cannot have received: anti-PD-1 therapy

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

Lab requirements

Blood counts

WBC ≥ 2 x 10^9/L; ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Haemoglobin ≥ 90g/L

Kidney function

Serum creatinine ≤ 1.5 x ULN; Creatinine clearance (CrCl) ≥ 40 mL/min using Cockroft-Gault formula

Liver function

Alanine transferase ≤ 2.5 x ULN; Aspartate transferase ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN (≤ 5 x ULN if Gilbert's Syndrome)

Adequate bone marrow function ... Adequate liver function ... Adequate renal function ...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06290505 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Are patients with ERBB2 alterations eligible?

No. ERBB2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation) is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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