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NCT05651594 · ClinicalTrials.gov registry record · Phase 2

Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by Roswell Park Cancer Institute.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT05651594 is a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 40 participants, below the 96-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05651594, a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

This phase II trial tests what effects the addition of propranolol to pembrolizumab and standard chemotherapy (mFOLFOX) may have on response to treatment in patients with esophageal or gastroesophageal junction cancer that cannot be removed by surgery and has spread to nearby tissue or lymph nodes (unresectable locally advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). Propranolol is a drug that is classified as a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Cancer patients may be under a tremendous amount of stress with elevated levels of norepinephrine (a hormone produced by the adrenal glands in response to stress). Increased adrenergic stress may dampen the immune system, which beta-blockers, like propranolol, may be able to counteract. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in the standard chemotherapy regimen, mFOLFOX (leucovorin, fluorouracil and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding propranolol to pembrolizumab and standard mFOLFOX chemotherapy may increase the effectiveness of the pembrolizumab + mFOLFOX regimen.

Conditions Studied

Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage II Esophageal Adenocarcinoma AJCC v8 Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Esophageal Adenocarcinoma Locally Advanced Gastroesophageal Junction Adenocarcinoma Unresectable Esophageal Adenocarcinoma Locally Advanced Esophageal Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • DRUG Fluorouracil
  • DRUG Leucovorin

Study Locations (1)

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-03-07
Est. Completion 2029-03-30
Phase Phase 2

Sponsor

Roswell Park Cancer Institute

365 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05651594

The ClinicalTrials.gov registry entry for NCT05651594 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (58% lower). The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05651594 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05651594 about?

NCT05651594 is a clinical study titled "Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma". This phase II trial tests what effects the addition of propranolol to pembrolizumab and standard chemotherapy (mFOLFOX) may have on response to treatment in patients with esophageal or gastroesophageal junction cancer that cannot be removed by surgery and has spread to nearby tissue or lymph nodes (...

What is the current status of trial NCT05651594?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-03-07. Estimated completion is 2029-03-30.

What conditions does trial NCT05651594 study?

This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8.

What interventions are being tested in trial NCT05651594?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Fluorouracil (DRUG), Leucovorin (DRUG).

Who is sponsoring clinical trial NCT05651594?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05651594 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.