NCT03368131

Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study

A Prospective Study of Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab for Siewert II ，III of HER-2 Positive Adenocarcinoma at Gastroesophageal Junction

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction

Conditions

• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Trastuzumab	intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle
DRUG	Capecitabine	825\~1000mg/m2 bid d1-14
DRUG	Oxaliplatin	130 mg/m2 Ivgtt d1 q3w
RADIATION	Radiotherapy	45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-12-30
• Completion: 2020-12-31
• First posted: 2017-12-11
• Last updated: 2020-02-19

Locations

1 site across 1 country: China