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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center Hospital East

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 to have been cured by local treatment shall not be included in active double cancers].

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Docetaxel
  • Oxaliplatin
  • Levofolinate
  • Fluorouracil (5-FU)
  • Radiation Therapy

Treatment groups

26 Participants
are divided into 1 treatment group

Sponsors and collaborators

National Cancer Center Hospital East

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator