NCT06235164

The Safety and Efficacy of Neoadjuvant Immunochemotherapy Followed by Laparoscopic Gastrectomy for Gastric Cancer

The Safety and Efficacy of Neoadjuvant Immunochemotherapy Followed by Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Real-world Clinical Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 585 (actual)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of laparoscopic gastrectomy (LG) following neoadjuvant immunochemotherapy (nICT)

Detailed description

comparing the radiological response, pathological response rate, perioperative outcomes, and early recurrence between the two groups.

Conditions

• Locally Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	immune checkpoint inhibitors: sintilimab, nivolumab, and camrelizumab	Drug: Sintilimab, Nivolumab, and Camrelizumab，One course will last 21 days.Given once every 3 weeks at a dose of 200 mg. Drug: nab-paclitaxel nab-paclitaxel one course will last 21 days#Given twice every 3 weeks at a dose of 125 mg/m2. Drug:oxaliplatin Oxaliplatin one course will last 21 days#Given once every 3 weeks at a dose of 130 mg/m2. Drug:docetaxel docetaxel one course will last 21 days#Given once every 3 weeks at a dose of 40mg/m2. Drug:fluorouracil fluorouracil one course will last 14 days#Given once every 2 weeks at a dose of 2800mg/m2. Drug: Capecitabine Capecitabine was calculated according to body surface area every 3 weeks at a dose of 1000 mg/m2, P.O., bid, d1-d14 Drug: S1 S-1 was calculated according to body surface area, P.O., bid, d1-d14#And the dosage according body surface area:\<1.25m2, 40mg everytime;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-12-30
• Completion: 2025-12-30
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: China