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Propranolol with Chemotherapy and Pembrolizumab for Esophageal/GEJ Cancer

This study is testing if adding propranolol to standard chemotherapy (mFOLFOX) and pembrolizumab can improve treatment response for people with esophageal or gastroesophageal junction (GEJ) cancer that cannot be removed by surgery or has spread. Propranolol is a beta-blocker, a type of medicine that affects your heart and blood flow. Researchers want to see if this combination helps shrink tumors. You may be eligible if you are newly diagnosed, have not had prior treatment for this specific cancer (or it was more than six months ago), and are at least 18 years old. The main goal is to see how many people respond to the treatment within six months. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 40 participants.
What's involved
You will undergo tumor biopsies, CT scans, and blood sample collections during screening and throughout the study. You will receive mFOLFOX6, pembrolizumab, and propranolol.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, overall response rate, is measured within 6 months of starting combination therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05651594

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~40 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyFluorouracilLeucovorinOxaliplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Within 6 months of initiating combination therapy

Conditions

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

Explore related trials

Esophageal AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT05651594

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Roswell Park Cancer Institute

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kannan Thanikachalam · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Kannan Thanikachalam
[email protected]
716-845-4005
Email the study team

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Eligibility criteria

Inclusion

Age \>= 18 years of age.
Participants must be newly diagnosed, treatment-naive with unresectable locally advanced or metastatic esophageal/gastroesophageal junction (GEJ) adenocarcinoma. Any prior systemic treatment for resectable disease must be six months or before. Prior PD-1/PD-L1 treatment is allowed as long as the treatment was completed more than 1 year ago.
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Available archival Formalin-Fixed Paraffin-Embedded (FFPE) from a prior biopsy collected within 1 year or, participant must be willing to have a tissue biopsy taken prior to start of study treatment.
Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present.
Platelet \>= 75,000/uL
Hemoglobin \>= 8 g/dL (without transfusion in the past 14 days)
Absolute Neutrophil Count (ANC) \>= 1500/uL
Creatinine clearance (Cockcroft Gault) \>= 30 mL/min
Total bilirubin: =\< 2 × upper limit of normal (ULN) OR direct bilirubin =\< ULN for participants with total bilirubin levels \> 2 × ULN
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase) (SGOT) and alanine transaminase (ALT) (serum glutamic-pyruvic transaminase) (SGPT) =\< 3 X institutional ULN (=\< 5 × ULN for participants with liver metastases)
Participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Ability to swallow and retain oral medication. If a patient is not able to swallow or is experiencing dysphagia that limits ability to swallow oral medication, they are still eligible for study provided they can swallow liquid formula propranolol or have an enteric feeding tube placed which will permit administration of crushed tablets or liquid formula propranolol. Liquid and tablet formulations may be used interchangeably for patients in the event of a shortage of either formulation
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion

Patients with HER 2-positive cancer.
Patients with active, untreated central nervous system metastases or leptomeningeal disease.
Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantation.
Patients currently treated with systemic immunosuppressive agents: If a patient is currently on steroids, they must be on a steroid dose less than or equal to an equivalent prednisone dose of 10 mg daily.
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment.
Has a concurrent Human Immunodeficiency Virus (HIV) infection.
Concurrent active Hepatitis B (defined as Hepatitis B virus surface antigen \[HBsAg\] positive and/or detectable Hepatitis B virus \[HBV\] deoxyribonucleic acid DNA) and Hepatitis C virus (defined as anti-HCV antibody \[Ab\] positive and detectable HCV ribonucleic acid \[RNA\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection.
Participants that are already on beta-adrenergic (B-AR) blockers for various indications.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\<2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Other active cancers that require systemic treatment.
Contraindications to the use of beta-blockers, e.g.: uncontrolled depression, unstable angina pectoris, uncontrolled heart failure ( Grade III or IV), hypotension (systolic blood pressure \<100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C \> 8.5 or fasting plasma glucose \> 160 mg/dl at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma etc.
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster etc.
Unwilling or unable to follow protocol requirements.
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.

What this trial measures

  • Overall response rate (ORR)Within 6 months of initiating combination therapy

    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.