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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: Recruiting 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Efficacy of pembrolizumab in combination with propranolol with standard chemotherapy measured by ORR by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, which is treated as a dichotomous variable and will be summarized using frequencies and relative frequencies.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-07 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 2 |
What NCT05651594 shows while recruiting
NCT05651594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, 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 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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05651594's enrollment target sits among peer trials
40 11th of 19 higher than 9 of 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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