RecruitingPhase 2NCT06290505

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

PALEO: Phase II Clinical Trial of Chemoradioimmunotherapy for the ALleviation of oEsOphageal Cancer Complications

Sponsor

Australasian Gastro-Intestinal Trials Group

Enrollment

54 participants

Start Date

Dec 8, 2021

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called the PALEO Study) is testing a combination of palliative chemotherapy, targeted radiation, and immunotherapy for people with esophageal cancer that has spread to a limited number of sites (1–5 spots outside the main tumor) or cancer that cannot be surgically removed. The goal is to ease symptoms and improve outcomes. **You may be eligible if...** - You are over 18 with biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) or cancer at the junction of the esophagus and stomach - Your cancer has spread to 1–5 sites, or it is locally advanced and not suitable for surgery or curative treatment - You have difficulty swallowing (dysphagia) - You are in reasonably good health (ECOG 0–2) with a life expectancy greater than 12 weeks - You weigh more than 30 kg and have adequate blood counts **You may NOT be eligible if...** - Your cancer has spread widely beyond 5 sites - You are not well enough to tolerate treatment - You have significant organ function problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Durvalumab will be supplied by AstraZeneca as a 500 mg vial concentrate for solution for infusion. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine-hydrochloride, 275 mM trehalose dihydrate, and 0.02% weight/volume (w/v) polysorbate 80; it has a pH of 6.0 and density of 1.054 g/mL. The label-claim volume is 10 mL. Durvalumab is a sterile, clear to opalescent, colorless to slightly yellow solution, free from visible particles. Investigational product vials are stored at 2°C to 8°C and must not be frozen. Investigational product must be kept in original packaging until use to prevent prolonged light exposure.