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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
200 mg Q3W on Day 1 by IV infusion
200 mg/m\^2 Q3W on Day 1 by IV infusion
1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
130 mg/m\^2 Q3W on Day 1 by IV infusion
Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy\*25.
Radical gastric cancer surgery with D2 lymph node dissection
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITING1 year Progression Free Survival (PFS)
Time frame: Approximately 3 years after the first participant is included
R0 surgical resection percentage
Time frame: Approximately 2 years after the first participant is included
Operative conversion percentage
Time frame: Approximately 2 years after the first participant is included
Overall survival (OS)
Time frame: Approximately 4 years after the first participant is included
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: Approximately 4 years after the first participant is included
Percentage of pathologic complete response(pCR)
Time frame: Approximately 2 years after the first participant is included
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