Actively Recruiting
Chemotherapy, Pembrolizumab, and Propranolol for Advanced Esophageal or Gastroesophageal Junction Adenocarcinoma
Led by Roswell Park Cancer Institute · Updated on 2025-12-16
40
Participants Needed
1
Research Sites
N/A
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
Researchers are studying patients with unresectable locally advanced or metastatic esophageal or gastroesophageal junction adenocarcinoma, which cannot be removed by surgery or has spread to other parts of the body. This phase II trial evaluates the effects of adding propranolol, a beta-blocker, to pembrolizumab immunotherapy and standard chemotherapy (mFOLFOX) to see if it improves treatment response. The study also explores how stress-related hormones might impact cancer treatment effectiveness. Participants receive a combination of treatments including mFOLFOX6 chemotherapy drugs (leucovorin, oxaliplatin, and fluorouracil) given intravenously, pembrolizumab immunotherapy given intravenously, and propranolol taken orally. Before starting treatment, patients undergo a tumor biopsy. During the study, they have CT scans and blood samples collected to monitor their condition and treatment effects. Throughout the trial, researchers assess the overall response rate within six months of starting treatment. They also monitor progression-free survival, overall survival, and safety for up to two years. Patients complete stress questionnaires, and researchers study changes in biomarkers and immune cells. Safety is checked through regular evaluations, and participation may last up to two years depending on treatment and disease progression.
CONDITIONS
Brief 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 completed at least 6 months prior
- 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 a new biopsy
- Measurable disease per RECIST 1.1 criteria
- Platelet count of at least 75,000/uL
- Hemoglobin level of at least 8 g/dL without transfusion in past 14 days
- Absolute neutrophil count of at least 1500/uL
- Creatinine clearance of at least 30 mL/min
- Total bilirubin less than or equal to 2 times upper limit of normal or direct bilirubin less than or equal to normal if total bilirubin is higher
- AST and ALT less than or equal to 3 times institutional upper limit of normal (or 5 times if liver metastases present)
- Negative pregnancy test for participants of child-bearing potential and agreement to use contraception
- Ability to swallow or retain oral medication or have feeding tube for propranolol
- Informed consent signed prior to study procedures
You will not qualify if you...
- HER 2-positive cancer
- Active, untreated central nervous system metastases or leptomeningeal disease
- Active autoimmune disease requiring ongoing immunosuppressive therapy or history of transplantation
- Current systemic immunosuppressive therapy exceeding prednisone 10 mg daily
- History of pneumonitis or interstitial lung disease requiring treatment
- Current HIV infection
- Active Hepatitis B or C infection
- Current use of beta-adrenergic blockers
- Prior radiotherapy within 2 weeks of study start unless palliative and recovered
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric illness
- Pregnant or nursing females
- Other active cancers needing systemic treatment
- Contraindications to beta-blockers including severe heart or lung conditions, uncontrolled diabetes, or specific vascular diseases
- Live vaccine within 30 days prior to trial treatment
- Unwillingness or inability to follow the study protocol
- Any condition making the participant unsuitable for study drug as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive mFOLFOX6 chemotherapy (leucovorin IV, oxaliplatin IV, and fluorouracil IV), pembrolizumab IV, and propranolol orally. Blood samples and CT scans are collected during treatment to monitor response and safety. Participants also complete questionnaires related to perceived stress.
Multiple visits for chemotherapy and pembrolizumab infusions as scheduled; blood samples and CT scans at baseline and periodically during treatment
Duration - Up to 2 years
Participants are monitored for progression-free survival, overall survival, and adverse events after completing treatment.
Periodic visits for up to 2 years after treatment completion
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here