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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

NCT07018570 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-08-26

No results posted yet for this study

Summary

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.

Conditions

  • Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

DRUG

Pembrolizumab

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

DRUG

Docetaxel

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

DRUG

Oxaliplatin

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

DRUG

Levofolinate

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

DRUG

Fluorouracil (5-FU)

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

RADIATION

Radiation Therapy

25Gy (5Gy×5fr)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2030-06-30
Completion
2031-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018570 on ClinicalTrials.gov