NCT05002686

Safety and Efficacy of Sintilimab in Combination With Chemoradiothrapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis

Safety and Efficacy of Sintilimab in Combination With Albumin-Paclitaxel/Oxaliplatin/Capecitabine and Radiotherapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis: A Multiple Center Single Arm Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. The purpose of this study is to estimate safety and efficacy of Sintilimab in combination with chemoradiothrapy followed by D2 surgical resection in patients with advanced gastric cancer with retroperitoneal lymph node metastasis.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	200 mg Q3W on Day 1 by IV infusion
DRUG	Albumin-Paclitaxel	200 mg/m\^2 Q3W on Day 1 by IV infusion
DRUG	Capecitabine	1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
DRUG	Oxaliplatin	130 mg/m\^2 Q3W on Day 1 by IV infusion
RADIATION	Radiation	Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy\*25.
PROCEDURE	Radical gastric cancer surgery	Radical gastric cancer surgery with D2 lymph node dissection

Timeline

• Start date: 2021-08-07
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2021-08-12
• Last updated: 2021-08-24

Locations

1 site across 1 country: China