NCT07018570View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

July 24, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2031

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)

Trial Locations (1)

277

RECRUITING

National Cancer Center Hospital East, Kashiwa

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

National Cancer Center Hospital East

OTHER

NCT07018570 - 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 | Biotech Hunter | Biotech Hunter