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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

ConditionGastroesophageal Junction (GEJ) 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab

    Drug

    Pembrolizumab 200mg will be administered via intravenous infusion over 30 minutes, twice at 21-day intervals.

  • Docetaxel

    Drug

    Docetaxel 50 mg/m2 will be administered over 60 minutes.

  • Oxaliplatin

    Drug

    Oxaliplatin 85 mg/m2 will be administered over 2 hours.

  • Levofolinate

    Drug

    Leucovorin 200 mg/m2 will be administered over 2 hours.

  • Fluorouracil (5-FU)

    Drug

    5-FU 2600 mg/m2 will be administered over 24 hours.

  • Radiation Therapy

    Radiation

    25Gy (5Gy×5fr)

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Pembrolizumab plus FLOT, RatiationExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

3-year event-free survival (EFS) rate

Time frame
3 years

Secondary outcomes

1

Organ-sparing survival

Time frame
3 years
2

Overall survival (OS)

Time frame
3 years
3

Clinical response rate

Time frame
3 years
4

Clinical complete response rate

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center Hospital East

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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