Study on Propranolol with Pembrolizumab and Chemotherapy for Treating Advanced Esophageal or Gastroesophageal Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05651594

Provider View

This clinical trial is exploring whether adding propranolol to pembrolizumab and standard chemotherapy can improve treatment outcomes for patients with esophageal or gastroesophageal cancer that cannot be surgically removed and has spread locally or to other parts of the body.

Patient Parameters

Program Overview

This study is testing a new treatment approach for esophageal or gastroesophageal junction cancer that cannot be removed by surgery and has spread. The treatment combines propranolol, a beta-blocker that may help reduce stress-related effects on the immune system, with pembrolizumab, an immunotherapy drug that helps the immune system attack cancer, and standard chemotherapy drugs (mFOLFOX). Researchers want to see if this combination can improve the effectiveness of the treatment.

Description

The main goal of this study is to see if adding propranolol to pembrolizumab and standard chemotherapy can effectively treat advanced esophageal or gastroesophageal junction cancer. Researchers will also look at how long patients live without the cancer getting worse, overall survival rates, and how well the treatment is tolerated.

Patients in the study will receive a combination of chemotherapy drugs (leucovorin, oxaliplatin, and fluorouracil), pembrolizumab, and propranolol. They will also have a tumor biopsy and undergo CT scans and blood tests to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Newly diagnosed with advanced esophageal or gastroesophageal junction cancer that cannot be removed by surgery.
  • No previous treatment for this type of cancer in the last six months.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Must have a tissue sample from a previous biopsy or be willing to have a new biopsy.
  • Have measurable cancer according to specific criteria.
  • Meet certain blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Must be able to swallow medication or have a feeding tube if needed.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Have HER2-positive cancer.
  • Have untreated brain or spinal cord cancer spread.
  • Have active autoimmune disease or need ongoing immunosuppressive therapy.
  • Have a history of lung disease that required treatment.
  • Have HIV or active hepatitis B or C infections.
  • Currently taking beta-blockers.
  • Have had recent radiation therapy or have not recovered from its effects.
  • Have uncontrolled health conditions like heart failure or psychiatric illness.
  • Pregnant or breastfeeding women.
  • Have other active cancers needing treatment.
  • Have conditions that prevent the use of beta-blockers.
  • Have received a live vaccine recently.
  • Unable or unwilling to follow study requirements.
  • Any condition that makes participation unsuitable according to the investigator.

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