Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy

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).

NCT Number	NCT06895447
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University Collaborators: Jiangsu Cancer Institute & Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
Conditions	Gastric Cancers
Enrollment	40 participants
Start Date	2024-11-14
Primary Completion	2025-11-14 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-01