FLOT and Pembrolizumab for GEJ Adenocarcinoma

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 2 Interventional 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.
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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.

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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.

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…
Contacts

Kohei Shitara, MD

+81-4-7133-1111

pemflot-tnt@east.ncc.go.jp

CONTACT

Izuma Nakayama, MD

+81-4-7133-1111

pemflot-tnt@east.ncc.go.jp

CONTACT