Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab

Sponsor
Simon C Pacey, MD
Study ID
NCT03653052
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Oesophageal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab will be administered via an infusion in the arm, over a duration of up to 1 hour.

Study Details

Patients with cancer are increasingly being treated with drugs designed to modulate the response of their immune system, broadly to boost their body's defences against cancer. However, there is an unmet need to identify which patients are unlikely to benefit. Deciding on benefit from therapy uses standard imaging methods (e.g. CT scans), which can take time (months) whereas DNA in the bloodstream could be measured more rapidly. The main aim of this study is to assess whether changes in the level of circulating tumour DNA (ctDNA) can quickly determine a patients response. This would enable patients to change therapies more quickly if they are not responding and reduce exposure to unnecessary side effects.

Key Dates

Start date
Oct 30, 2018
Status verified
Apr 2025
Primary completion
Nov 11, 2021
Completion
Jun 30, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    Patients with advanced oesophageal cancer will be administered with 1500mg of durvalumab once every 4 weeks for up to 6 months.

Primary Outcome Measure

Clinical response to therapy (durvalumab) [ Time Frame: 26 weeks ]

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