esophagogastric junction carcinoma
Conditions
Interventions
This study was designed to evaluate the efficacy and safety of total neoadjuvant therapy (TNT), including pembrolizumab, FLOT, and short-course radiotherapy, for patients with resectable esophagogastr
Sponsors
NAKAYAMA IZUMA
Eligibility
Sex/Gender
All
Inclusion 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 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 count>=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 (described in Appendix 5) 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
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]. *Active double cancers which require intensive treatments and possibly affect continuation of protocol treatment. This criterion shall not be violated if protocol treatment and surgery can be performed without interference and if the treatment and course of the double cancers themselves are not adversely affected. For example, this shall also apply to prostate cancer that is treated only with hormone therapy. 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 (see Section 6.5.2) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event-free survival (EFS) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Organ-sparing survival, overall survival (OS), clinical response rate, clinical complete response rate, major pathological response rate, pathological complete response rate, radical resection rate, TNT completion rate, treatment completion rate, adverse event incidence rate, ctDNA clearance after treatment, EORTC QLQ-C30, and EORTC QLQ-OG25 | — |
Contacts
Public ContactSecretariat of clinical trial coordinating committ
National Cancer Center Hospital East
Outcome results
None listed