Actively Recruiting
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
Led by National Cancer Center Hospital East · Updated on 2025-08-26
26
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center Hospital East
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed esophagogastric junction adenocarcinoma.
- Patients naive to systemic therapy with esophagogastric junction carcinoma of Siewert Type I to III classified as T2-4, any N, and M0.
- Patients aged 18 years or older at the time of consent.
- Patients with ECOG Performance Status of 0 or 1.
- Recent laboratory values within 14 days meeting neutrophil count 61500/mm3, hemoglobin 619.0 g/dL, platelet count 61100,000/mm3, total bilirubin 6141.5 mg/dL, AST 64100 IU/L, ALT 64100 IU/L, and serum creatinine 641.5 mg/dL.
- No blood transfusion within 7 days before registration.
- Female patients of childbearing potential with a negative pregnancy test within 14 days before registration.
- Agreement to use highly effective contraception during the study and for 120 days after stopping the study drug.
- Consent to provide samples for biomarker analysis.
- Written informed consent to participate in the study.
You will not qualify if you...
- History of use of anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
- History of acute coronary syndrome, coronary angioplasty, or stent implantation within 6 months before registration.
- History or findings of congestive heart failure Class II or higher (NYHA classification).
- Active double cancers within 2 years, excluding cured carcinoma in situ or intramucosal carcinoma.
- Serious complications requiring hospitalization (e.g., intestinal obstruction, pulmonary fibrosis, difficult-to-control diabetes, cardiac failure, psychiatric or cerebrovascular disorders).
- Active hepatitis B or hepatitis C infection.
- History of HIV infection.
- Complicated interstitial lung disease or history of pneumonitis requiring steroids.
- Receipt of live vaccine within 30 days before starting investigational drug.
- Concomitant or history of chronic/recurrent autoimmune disease.
- Current or recent systemic corticosteroids or immunosuppressive medication within 14 days before registration.
- Unhealed wounds, ulcers, or fractures.
- Pregnant or lactating patients.
- Unable or unwilling to comply with study protocol.
- Investigator judgment of ineligibility for the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277
Actively Recruiting
Research Team
K
Kohei Shitara, MD
CONTACT
I
Izuma Nakayama, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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