NCT05918419

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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)

Conditions

• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Serplulimab	PD-1 antibody

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: China