Efficacy and Safety of Minimally Invasive D2+PAND Gastrectomy for Gastric Cancer With PAN Metastasis After Conversion Immunochemotherapy

NCT07056010 | Recruiting

• 1 other identifier: CICL-D2PAND
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• postoperative complications within 30 days after surgery

  Early Postoperative Complications: Complications occurring within 30 days post-surgery (number of participants with treatment-related adverse events as assessed by CTCAE v4.0)

  30 days after surgery

Secondary Outcomes (3)

• Neoadjuvant treatment efficacy

  2 weeks after surgery

• TRG

  2 weeks after surgery

• pCR

  2 weeks after surgery

Study Arms (1)

patients will undergo curative minimally invasive gastrectomy with D2+PAND

EXPERIMENTAL

Procedure: curative minimally invasive gastrectomy with D2+PAND lymphadenectomy

Interventions

curative minimally invasive gastrectomy with D2+PAND lymphadenectomy PROCEDURE

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.

patients will undergo curative minimally invasive gastrectomy with D2+PAND

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Expected survival of ≥6 months.
• Measurable tumor lesions as defined by RECIST v1.1 criteria (see Attachment 1).
• Preoperative ECOG performance status score (see Attachment 2) of 0 or 1.
• Good cardiac function, capable of undergoing a curative resection. If there are clinical indications, patients with underlying ischemic, valvular heart disease, or other serious heart conditions should undergo preoperative assessment by a cardiologist.
• Normal major organ function, with the following laboratory criteria:
• Absolute neutrophil count (ANC) ≥ 1.2 x 10\^9/L in the absence of granulocyte colony-stimulating factor use within the past 14 days.
• Platelet count ≥ 100 x 10\^9/L in the absence of blood transfusion within the past 14 days.
• Hemoglobin \> 8 g/dL in the absence of blood transfusion or erythropoietin use within the past 14 days.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
• Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min.

You may not qualify if:

• 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.
• Emergency surgery performed due to complications of gastric cancer (e.g., bleeding, obstruction, or perforation).
• Patients preparing for or with a history of organ or bone marrow transplantation.
• Blood transfusion within 2 weeks prior to surgery or a history of bleeding disorders, or any severe bleeding event (grade 3 or above according to CTCAE 4.0) occurring within 4 weeks prior to surgery.
• Coagulation disorders or bleeding tendencies (INR \> 1.5 without anticoagulant use); patients receiving anticoagulants or vitamin K antagonists, such as warfarin, heparin, or similar agents. Low-dose warfarin (1 mg oral daily) or low-dose aspirin (≤100 mg daily) may be allowed for preventive purposes, provided the prothrombin time international normalized ratio (INR) is ≤ 1.5.
• History of thromboembolic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening. Patients with venous thrombosis caused by prior chemotherapy and deemed healed by the investigator are excluded.
• Myocardial infarction, poorly controlled arrhythmias (including QTc interval \> 450 ms for males and \> 470 ms for females) within 6 months prior to surgery. QTc interval should be calculated using the Fridericia formula.
• NYHA class III or IV heart failure, or left ventricular ejection fraction (LVEF) \< 50% as per echocardiogram.
• Pulmonary dysfunction with FEV1 \< 50% of predicted value.
• Urinary protein ≥++ on routine urinalysis, confirmed by 24-hour urinary protein quantification \> 1.0 g.
• Clinically symptomatic pleural effusion or ascites requiring clinical intervention.
• Human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical Unviersity

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

XU

CONTACT

862568306505; liuhongda@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: November 25, 2024
• Primary Completion: November 25, 2025
• Study Completion (Estimated): November 25, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

CN (1)