Radio-immuno-chemotherapy for Esophageal Cancer
(OPERARADIO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBiniam Kidane

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Manitoba

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for adults over 18 with early-stage esophageal cancer (T1b/T2N0) who have completed a specific type of surgery (EMR/ESD), can't or won't get their esophagus removed, and meet certain health requirements like body weight and blood counts.

Inclusion Criteria

I have completed a procedure to remove part of the inner layers of my stomach or esophagus.

I am older than 18 years.

Able to provide informed consent

+4 more

Exclusion Criteria

I have or had an autoimmune or inflammatory disorder.

Participation in another clinical study with an investigational product during the last 4 weeks

History of allogenic organ transplantation

+16 more

Participant Groups

The study tests the safety of two additional treatments after surgery: one group gets chemo plus radiation (chemoradiation), while another gets immune therapy plus radiation. The goal is to enroll 10 patients to see if these approaches are safe.

2Treatment groups

Experimental Treatment

Group I: Adjuvant chemoradiotherapyExperimental Treatment1 Intervention

Some patients have medical conditions, i.e., severe auto-immune disease that prohibits them from receiving immunotherapy. In such patients, adjuvant therapy will be provided in the form of concurrent chemoradiotherapy (ARM2).

Group II: Adjuvant Immunoradiotherapy (ARM1) and Adjuvant Immunotherapy (ARM1B)Experimental Treatment1 Intervention

The primary/preferred adjuvant therapy will be immunoradiotherapy (ARM1); however, if this combination is felt to be too high-risk for specific patients, the next preferred therapy will be immunotherapy without radiation (ARM1B).