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
Recruiting
Phase 2Interventional Study
Gastroesophageal Junction (GEJ) Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
26 (estimated)
Sponsor
National Cancer Center Hospital East · Other
Who this trial is looking for
This trial is looking for patients with locally advanced gastroesophageal junction adenocarcinoma. Participants will receive a treatment that includes chemotherapy and immunotherapy before deciding on surgery or other options.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with gastroesophageal junction adenocarcinoma.
I am at least 18 years old.
I have not received any prior systemic therapy.
My health status is good (ECOG PS 0 or 1).
I meet specific lab test values.
I have tested negative for pregnancy if I am female and of childbearing potential.
I agree to use effective contraception during the trial.
I have consented to provide samples for analysis.
You may not be able to join if
I have had an anti-PD-1 or anti-PD-L1 antibody treatment before.
I have had heart problems in the last 6 months.
I have chronic heart failure.
I have active double cancers.
I have serious health complications requiring hospitalization.
I have active hepatitis B or C.
I have a history of HIV.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
\<Inclusion Criteria\>
1. Patients with histologically confirmed esophagogastric junction adenocarcinoma.
2. 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 UIC…
\<Inclusion Criteria\>
1. Patients with histologically confirmed esophagogastric junction adenocarcinoma.
2. 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.
3. Patients aged 18 years or older as of the day of informed consent.
4. Patients with ECOG Performance Status (PS) 0 or 1.
5. 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).
\[1\] Neutrophil count ≥1,500/mm3 \[2\] Hemoglobin ≥9.0 g/dL \[3\] Platelet counts ≥100,000/mm3 \[4\] Total bilirubin ≤1.5 mg/dL \[5\] AST (GOT) ≤100 IU/L \[6\] ALT (GPT) ≤100 IU/L \[7\] Serum creatinine ≤1.5 mg/dL 6) Patients who did not receive blood transfusion within 7 days before registration (ineligible if transfusion was performed on the same day of the week one week before the date of registration).
7)Female patients of childbearing potential who tested negative for pregnancy within 14 days before registration. Male and female patients who have agreed to practice appropriate highly effective contraception with low user dependency during the study and for up to 120 days after discontinuation of the investigational drug.
8)Patients who have given consent to provide samples for biomarker analysis. 9)Patients who have given their own written consent to participate in the study
\<Exclusion Criteria\>
1. Patients with a history of using an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.
2. Patients with a history of acute coronary syndrome (including myocardial infarction and angina unstable), coronary angioplasty, or stent implantation within 6 months before registration.
3. 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.
4. Patient with active double cancers \[simultaneous double cancers and metachronous double cancers with a disease-free interval of ≤2 years. However, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to have been cured by local treatment shall not be included in active double cancers\].
5. Patients with serious (requiring hospitalization) complications (e.g., intestinal paralysis, intestinal obstruction, pulmonary fibrosis, difficult-to-control diabetes mellitus, cardiac failure, myocardial infarction, angina unstable, renal failure, hepatic failure, psychiatric disorder, cerebrovascular disorder).
6. Patients with active hepatitis B (HBs antigen positive) or hepatitis C.
7. Patients with a history of HIV.
8. Patients with complicated interstitial lung disease/pneumonitis or with a history of (non-infectious) interstitial lung disease/pneumonitis requiring steroid administration.
9. Patients who received a live vaccine within 30 days before the start of investigational drug administration.
10. Patients with concomitant autoimmune disease or a history of chronic or recurrent autoimmune disease.
11. 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 those who have received any of these treatments within 14 days before registration in this study.
12. Patients with unhealed wounds (requiring sutures, antimicrobial administration, and cleaning procedures), ulcers, or fractures.
13. Pregnant or lactating patients.
14. Patients who are unwilling or unable to comply with the study protocol.
15. Patients deemed by the investigator to be ineligible for this study.
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