NCT05387681

Preoperative Short Course Radiotherapy With Envafolimab, Endostatin and SOX Regimen in Locally Advanced Gastric

An Exploratory Clinical Study of Short-course Radiotherapy Combined With Envafolimab, Endostatin and SOX Regimen for Neoadjuvant Treatment of Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, exploratory clinical study to evaluate the efficacy and safety of Preoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen in resectable locally advanced gastric/gastroesophageal junction adenocarcinoma.

Detailed description

All eligible subjects will receive 5\*5Gy (25Gy/5F) fractionated radiotherapy, rest for 1 week, 3 cycles of Envafolimab, Endostatin and SOX regimen, and radical surgery 2 to 4 weeks after completion of the last neoadjuvant therapy, according to the study plan. Each patient will be followed up 12 months after initiation of treatment in the study. Whether the subjects need adjuvant therapy after surgery and the adjuvant treatment plan are determined by the investigator. All subjects were required to complete the study follow-up plan after surgery.

Conditions

• Gastric/Gastroesophageal Junction Adenocarcinoma
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Envafolimab	short course radiotherapy ：5\*5Gy (25Gy/5F) ； Envafolimab：300 mg, subcutaneously, D1, Q3W; Endostatin ：210mg (14 doses), CIV continuously pumped for 72h, Q3W; chemotherapy：SOX regimen

Timeline

• Start date: 2022-05-30
• Primary completion: 2023-07-30
• Completion: 2025-12-30
• First posted: 2022-05-24
• Last updated: 2022-05-24