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RECRUITING
NCT07018570
PHASE2

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

Sponsor: National Cancer Center Hospital East

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-07-24

Completion Date

2031-06

Last Updated

2025-08-26

Healthy Volunteers

No

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)

Locations (1)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan