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).
Aged 18 to 80 years, regardless of gender.
Histologically confirmed gastric cancer or gastroesophageal junction (GEJ) cancer that has received neoadjuvant therapy, with pathology confirming it is predominantly adenocarcinoma. For GEJ cancer, only Siewert Type III and Siewert Type II cases that do not require combined thoracotomy are eligible.
Tumor stage confirmed as cStage III, suitable for curative R0 resection, as determined by an evaluation by a gastrointestinal surgeon and a radiologic technician prior to enrollment. The patient agrees to undergo robotic-assisted radical surgery, and the surgeon judges there are no surgical contraindications.
Expected survival of ≥6 months.
Patients with a history of (within the past 5 years) or current active malignancies. However, patients with cured localized tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, stage I colorectal cancer, etc., are eligible.
A history of upper abdominal surgery (except for laparoscopic cholecystectomy).
A history of gastric resection, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
Patients requiring surgery for other diseases concurrently.
Single group
Pre-operative chemotherapy
DrugPatients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted).
Robotic radical gastrectomy after neoadjuvant therapy
Procedure/SurgeryEligible 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.
safety and clinical efficacy of robotic radical gastrectomy following neoadjuvant therapy
Early Postoperative Complications: Complications occurring within 30 days post-surgery (number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Neoadjuvant treatment efficacy
R0 resection rate after neoadjuvant therapy
Postoperative quality of life assessment
Postoperative quality of life assessment (Physicians Global Assessment)
Long-term complications (31 days to 3 years post-surgery)
Long-term complications (31 days to 3 years post-surgery)
Pathological response rate
Include pathological complete response (pCR) rate, major pathological response (MPR) rate after neoadjuvant therapy, tumor regression grade (TRG) after neoadjuvant therapy, clinical downstaging rate (T and/or N downstaging) after neoadjuvant therapy, objective response rate (ORR) and disease control rate (DCR) after neoadjuvant therapy (RECIST v1.1)
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Jiangsu Cancer Institute & Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
