Efficacy and Safety of Minimally Invasive D2+PAND Gastrectomy for Gastric Cancer With PAN Metastasis After Conversion Immunochemotherapy
Trial Parameters
Brief Summary
This is a prospective, open-label, single-center, Phase II clinical trial. Thirty patients with HER2-negative gastric adenocarcinoma or gastroesophageal junction (GEJ) cancer, presenting with PAN metastasis (No. 16 lymph nodes ≥10 mm), will be enrolled. Participants will receive four cycles of conversion immunochemotherapy with a PD-1 inhibitor (Serplulimab) combined with the SOX chemotherapy regimen (oxaliplatin and S-1). After completion of conversion therapy, patients will undergo curative minimally invasive (laparoscopic or robotic) gastrectomy with D2+PAND lymphadenectomy
Eligibility Criteria
Inclusion Criteria: * 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 IV （ para-aortic lymph node enlargement without other distant metastatic factors）, suitable for curative R0 resection, as determined by an evaluation by a gastrointestinal surgeon and a radiologic technician prior to enrollment. The patient consented to conversion therapy followed by radical surgical resection, with no surgical contraindications confirmed by the attending surgeon. * No. 16 lymph nodes ≥10 mm * Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; * Exp