OncoMatch/Clinical Trials/NCT06895447
Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy
Is NCT06895447 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pre-operative chemotherapy for gastric cancers.
Treatment: Pre-operative chemotherapy — 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).
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant therapy — neoadjuvant
Lab requirements
Blood counts
ANC ≥ 1.2 x 10^9/L (no G-CSF within 14 days), platelets ≥ 100 x 10^9/L (no transfusion within 14 days), hemoglobin > 8 g/dL (no transfusion or erythropoietin within 14 days).
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min.
Liver function
Total bilirubin ≤ 1.5 × ULN; if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN, inclusion is permitted. AST and ALT ≤ 2.5 × ULN.
Cardiac function
Good cardiac function, capable of undergoing curative resection. If clinical indications, preoperative cardiologist assessment required. Myocardial enzyme profile within normal range (clinically insignificant isolated abnormalities allowed).
Good cardiac function, capable of undergoing a curative resection... Normal major organ function, with the following laboratory criteria: ANC ≥ 1.2 x 10^9/L... Platelet count ≥ 100 x 10^9/L... Hemoglobin > 8 g/dL... Total bilirubin ≤ 1.5 × ULN... AST and ALT ≤ 2.5 × ULN... Serum creatinine ≤ 1.5 × ULN and creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min... Coagulation function defined by INR or PT ≤ 1.5 × ULN... Normal thyroid function... Normal range for myocardial enzyme profile...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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