BridgeMD
New treatment option for Gastroesophageal Junction (GEJ) Adenocarcinoma
Official title An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07018570
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastroesophageal junction (gej) adenocarcinoma.
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 study is to evaluate the effectiveness of treatment for esophagogastric junction carcinoma, total neoadjuvant therapy (TNT) including pembrolizumab and FLOT is conducted, aiming to choose between surgery or organ preservation treatment strategies.
- 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
- Patients with histologically confirmed esophagogastric junction adenocarcinoma.
- Patients who are naive to systemic therapy and have esophagogastric junction carcinoma of Siewert Type I to III classified as T: 2-4, N: any, and M...
- Patients aged 18 years or older as of the day of informed consent.
- Patients with ECOG Performance Status (PS) 0 or 1.
- Patients whose most recent laboratory values within 14 days before registration meet all of the following criteria (testing on the same day of the...
You likely can't join if
- Patients with a history of using an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.
- Patients with a history of acute coronary syndrome (including myocardial infarction and angina unstable), coronary angioplasty, or stent implantation...
- Patients with a history or findings of congestive heart failure of Class II or higher according to the New York Heart Association (NYHA)...
- Patient with active double cancers [simultaneous double cancers and metachronous double cancers with a disease-free interval of ≤2 years. However...
- Patients with serious (requiring hospitalization) complications (e.g., intestinal paralysis, intestinal obstruction, pulmonary fibrosis...
- Patients with active hepatitis B (HBs antigen positive) or hepatitis C.
See the full eligibility criteria
- Patients with histologically confirmed esophagogastric junction adenocarcinoma.
- Patients who are naive to systemic therapy and have esophagogastric junction carcinoma of Siewert Type I to III classified as T: 2-4, N: any, and M: 0 according to the 8th edition of the UICC-TNM classification.
- Patients aged 18 years or older as of the day of informed consent.
- Patients with ECOG Performance Status (PS) 0 or 1.
- Patients whose most recent laboratory values within 14 days before registration meet all of the following criteria (testing on the same day of the week two weeks before the date of registration is acceptable). [1]...
- Patients with a history of using an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.
- Patients with a history of acute coronary syndrome (including myocardial infarction and angina unstable), coronary angioplasty, or stent implantation within 6 months before registration.
- Patients with a history or findings of congestive heart failure of Class II or higher according to the New York Heart Association (NYHA) classification of cardiac function.
- Patient with active double cancers [simultaneous double cancers and metachronous double cancers with a disease-free interval of ≤2 years. However, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged...
- Patients with serious (requiring hospitalization) complications (e.g., intestinal paralysis, intestinal obstruction, pulmonary fibrosis, difficult-to-control diabetes mellitus, cardiac failure, myocardial infarction...
- Patients with active hepatitis B (HBs antigen positive) or hepatitis C.
- Patients with a history of HIV.
- Patients with complicated interstitial lung disease/pneumonitis or with a history of (non-infectious) interstitial lung disease/pneumonitis requiring steroid administration.
- Patients who received a live vaccine within 30 days before the start of investigational drug administration.
- Patients with concomitant autoimmune disease or a history of chronic or recurrent autoimmune disease.
- Patients who require systemic corticosteroids (except for prophylactic administration for testing or allergic reactions, or temporary use to reduce edema associated with radiotherapy) or immunosuppressive medication, or...
- Patients with unhealed wounds (requiring sutures, antimicrobial administration, and cleaning procedures), ulcers, or fractures.
- Pregnant or lactating patients.
- Patients who are unwilling or unable to comply with the study protocol.
- Patients deemed by the investigator to be ineligible for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Kashiwa, Chiba, Japan
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 Kashiwa, Chiba, Japan. 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.