Actively Recruiting
Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma
Led by Roswell Park Cancer Institute · Updated on 2025-12-16
40
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed, treatment-naive with unresectable locally advanced or metastatic esophageal/gastroesophageal junction adenocarcinoma
- Prior systemic treatment for resectable disease allowed if given 6 months or more ago
- Prior PD-1/PD-L1 treatment allowed if completed more than 1 year ago
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Available archival biopsy tissue within 1 year or willingness to have biopsy before treatment
- Measurable disease by RECIST 1.1 criteria
- Platelet count of 75,000/uL or higher
- Hemoglobin 8 g/dL or higher without transfusion in past 14 days
- Absolute neutrophil count (ANC) 1500/uL or higher
- Creatinine clearance of 30 mL/min or higher
- Total bilirubin less than or equal to 2 times upper limit of normal (ULN) or direct bilirubin less than or equal to ULN if total bilirubin is higher
- AST and ALT less than or equal to 3 times institutional ULN (or 5 times ULN if liver metastases present)
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Ability to swallow and retain oral medication or use liquid/feeding tube propranolol
- Understanding of study and signed informed consent
You will not qualify if you...
- HER 2-positive cancer
- Active, untreated central nervous system metastases or leptomeningeal disease
- Active autoimmune disease requiring immunosuppressive therapy or history of transplantation
- Current systemic immunosuppressive treatment exceeding prednisone 10 mg daily equivalent
- History of pneumonitis or interstitial lung disease requiring treatment
- HIV infection
- Active Hepatitis B or C infection
- Current use of beta-blockers
- Radiotherapy within 2 weeks before study treatment without recovery
- Uncontrolled illnesses like infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Pregnant or nursing female participants
- Other active cancers needing systemic treatment
- Contraindications to beta-blockers including uncontrolled depression, heart failure grade III/IV, low blood pressure, severe asthma/COPD, uncontrolled diabetes, peripheral arterial disease, untreated pheochromocytoma
- Receipt of live vaccine within 30 days before first dose
- Inability or unwillingness to follow study requirements
- Any condition making participant unsuitable for study drug per investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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