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Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction — SNACRT  

Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:
Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction: a Single-arm,Open-label，Phase II Clinical Study

Clinical Trial Summary

Investigators conduct the clinical trial to further explore the efficacy and safety of Neoadjuvant chemoradiation Plus Serpluimab in Patients with locally advanced Adenocarcinoma of Gastroesophageal Junction

Clinical Trial Description

1. Target population: patients with locally advanced adenocarcinoma of Gastroesophageal Junction (cT3-4aN+M0). 2. Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus Serpluimab in patients with locally advanced Adenocarcinoma of Gastroesophageal Junction 3. Patients will be given the perioperative treatment as below once recruited: induction chemotherapy ：Serplulimab 300mg iv.gtt d1+Oxaliplatin130mg/m2 iv.gtt d1,+S1 40mg/m2 p.o.b.i.d. d1~d14（up to 60mg) .Every three weeks for one cycle. After the induction chemotherapy，concurrent chemoradiation will be strated：Serplulimab 300mg iv.gtt d1,+Oxaliplatin100mg/m2 iv.gtt d1+S1 40mg/m2 p.o.b.i.d. d1~d14(up to 60mg), every three weeks , the total of two cycles . Radiation total dose: 45Gy/25F, 1.8Gy/d. Resectable patients will receive D2 resection After 6-8weeks Neoajuvant therapy 4. Number of subjects: 35 patients. Number of centers: 1 site(Peking Union Medical College Hospital) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05918419
Study type Interventional
Source Peking Union Medical College Hospital
Contact Zhao Lin
Phone 010-69156874
Email wz20010727@aliyun.com
Status Recruiting
Phase Phase 2
Start date February 1, 2023
Completion date September 1, 2024
View Details
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