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Organ-Preserving Endoscopic Resection & Adjuvant RADIO-immuno-chemotherapy for Esophageal Cancer

NCT05667298 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-05-11

No results posted yet for this study

Summary

The goal of this study is to assess the safety of delivering concurrent adjuvant chemoradiation or immuno-radiation therapy after EMR/ESD in pT1b/T2N0 esophageal cancer patients. The main objectives of the study are:

1. Assess the feasibility of enrolling 10 patients.
2. Assess the safety of delivering concurrent adjuvant chemoradiation or immunoradiation therapy after EMR/ESD in pT1b/T2 esophageal cancer patients

Conditions

  • Esophageal Cancer

Interventions

DRUG

Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B)

Durvalumab treatment is to begin six weeks following patient ESD/EMR surgery. Patients may delay dosing under the following certain circumstances: 1. Dosing may be delayed per Toxicity Management Guidelines (Appendix IV), due to either an immune or a non-immune-related AE. 2. Dosing intervals of subsequent cycles may be shortened as clinically feasible in order to gradually align treatment cycles with the schedule of tumor efficacy (RECIST) and PRO assessments. Subsequent time between 2 consecutive doses cannot be less than 22 days, based on the half-lives of durvalumab (see current Investigator Brochure for durvalumab). 3. Standard of Care Arm (CROSS): 4. Patients may delay and subsequently resume dosing per local standard clinical practice. If dosing must be delayed for reasons other than treatment-related toxicity, dosing will occur as soon as feasible.

DRUG

Adjuvant chemoradiotherapy

Durvalumab treatment is to begin six weeks following patient ESD/EMR surgery. Patients may delay dosing under the following certain circumstances: 1. Dosing may be delayed per Toxicity Management Guidelines (Appendix IV), due to either an immune or a non-immune-related AE. 2. Dosing intervals of subsequent cycles may be shortened as clinically feasible in order to gradually align treatment cycles with the schedule of tumor efficacy (RECIST) and PRO assessments. Subsequent time between 2 consecutive doses cannot be less than 22 days, based on the half-lives of durvalumab (see current Investigator Brochure for durvalumab). 3. Standard of Care Arm (CROSS): 4. Patients may delay and subsequently resume dosing per local standard clinical practice. If dosing must be delayed for reasons other than treatment-related toxicity, dosing will occur as soon as feasible.

Sponsors & Collaborators

  • Manitoba Medical Service Foundation

    collaborator OTHER

  • CancerCare Manitoba

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Biniam Kidane · University of Manitoba

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-06-20
Completion
2029-07-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667298 on ClinicalTrials.gov