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New treatment option for Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Official title Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT05651594
What this study is testing
What is Fluorouracil?
Fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage ii esophageal adenocarcinoma ajcc v8.
Also referred to as 5 Fluorouracil, 5 Fluorouracilum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years of age.
- Participants must be newly diagnosed, treatment-naive with unresectable locally advanced or metastatic esophageal/gastroesophageal junction (GEJ)...
- 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...
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present.
You likely can't join if
- 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...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment.
- Has a concurrent Human Immunodeficiency Virus (HIV) infection.
See the full eligibility criteria
- 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...
- 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 × 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...
- 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...
- 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...
- 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...
- 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]...
- 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...
- 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...
- 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...
- 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 \ 8.5 or fasting plasma glucose...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.