Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy
Status:
RECRUITING
Trial end date:
2028-12-30
Target enrollment:
Participant gender:
Summary
This study is a prospective, open-label, single-arm phase II clinical trial designed to evaluate the safety and efficacy of robotic radical gastrectomy in patients with locally advanced gastric adenocarcinoma after undergoing neoadjuvant therapy. Conducted at multiple centers, the study aims to include 40 patients confirmed via histopathological and/or cytological analysis. Eligible participants must have stage III resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma based on imaging studies such as ultrasound endoscopy, CT, or MRI.
Patients will receive 3-4 cycles of neoadjuvant therapy, followed by imaging evaluations to assess the treatment response and determine eligibility for radical D2 gastrectomy. Within 2-6 weeks of the final neoadjuvant treatment cycle, eligible patients will undergo robotic radical gastrectomy. Key outcomes include post-surgical complications, pathological responses (pCR, MPR, TRG), and objective response rates (ORR), alongside disease-free survival (DFS) and overall survival (OS).
Phase:
PHASE2
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborators:
Affiliated Hospital of Nanjing University of Chinese Medicine Jiangsu Cancer Institute & Hospital The Affiliated Hospital of Xuzhou Medical University The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School