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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: National Cancer Center Hospital East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Immunochemotherapy before short-term radiation therapy, pembrolizumab 200mg will be intravenously infused at 21-day intervals for 2 doses. FLOT (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200mg/m2, 5-FU 2600 mg/m2) will be intravenously infused at 14-day intervals for 2 doses. Regarding short-term radiotherapy, irradiation will be delivered from day1 to day5, with a dose of 5 Gy per fraction for a total of 25 Gy. In Immunochemotherapy after short-term radiation therapy, pembrolizumab 200mg will be intravenously infused on day 8. FLOT will be intravenously infused on day 1 and day15. If CR or Near CR is achieved after the first and second efficacy assessment, pembrolizumab 200mg will be intravenously infused at 21-day intervals for 14 doses and FLOT will be intravenously infused at 14-day intervals for 4 doses as immunochemotherapy as non-operative management (NOM). If CR or Near CR is not achieved after the first or second efficacy assessment, surgery will be performed. And then pembrolizumab 200mg will be intravenously infused at 21-day intervals for 14 doses and FLOT will be intravenously infused at 14-day intervals for 4 doses as Postoperative adjuvant immunochemotherapy.

Conditions

• Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-07-24
• Primary completion: 2030-06-01
• Completion: 2031-06-01
• First posted: 2025-06-12
• Last updated: 2025-08-26

Locations

1 site across 1 country: Japan