Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07056010

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-07-09

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years, regardless of gender.
  • Histologically confirmed gastric cancer or gastroesophageal junction (GEJ) cancer with predominantly adenocarcinoma.
  • For GEJ cancer, only Siewert Type III and Type II cases not requiring combined thoracotomy.
  • Tumor stage cStage IV with para-aortic lymph node enlargement and suitable for curative R0 resection.
  • Para-aortic lymph nodes (No. 16) measuring 10 mm or larger.
  • No prior systemic treatment, except neoadjuvant chemotherapy completed over 6 months ago.
  • Expected survival of at least 6 months.
  • Measurable tumor lesions per RECIST v1.1 criteria.
  • ECOG performance status score of 0 or 1.
  • Good cardiac function allowing curative surgery; preoperative cardiology assessment if indicated.
  • Normal major organ function meeting specified blood count, liver, kidney, coagulation, and thyroid function criteria.
  • Weight of at least 40 kg or BMI greater than 18.5.
  • Signed informed consent form.
Not Eligible

You will not qualify if you...

  • History of or current active malignancies within the past 5 years, except certain cured localized tumors.
  • Previous upper abdominal surgery except laparoscopic cholecystectomy.
  • Previous gastric resection, endoscopic mucosal resection, or submucosal dissection.
  • Need for surgery for other diseases at the same time.
  • Emergency surgery due to gastric cancer complications.
  • History or preparation for organ or bone marrow transplantation.
  • Blood transfusion within 2 weeks before surgery or bleeding disorders.
  • Coagulation disorders or use of anticoagulants except low-dose preventive use.
  • History of thromboembolic events within 6 months.
  • Recent myocardial infarction or poorly controlled arrhythmias within 6 months.
  • Severe heart failure or low left ventricular ejection fraction.
  • Pulmonary dysfunction with low lung function.
  • Significant urinary protein or symptomatic pleural effusion/ascites.
  • HIV infection or active pulmonary tuberculosis.
  • Chronic non-healing wounds or fractures.
  • History of serious lung diseases or severe pulmonary dysfunction.
  • Active or suspected autoimmune diseases requiring systemic immunosuppressive therapy.
  • Severe chronic autoimmune diseases, active hepatitis B or C, or HIV infections.
  • Need for systemic corticosteroids or immunosuppressive drugs recently.
  • Active infection requiring systemic antibiotics within 14 days.
  • Recent live vaccinations within 28 days.
  • Participation in another surgery-related clinical trial.
  • History of alcoholism, drug abuse, or substance misuse.
  • Noncompliance with medical instructions or incomplete data.
  • Pregnancy or breastfeeding.
  • Other conditions increasing risk or deemed unsuitable by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Nanjing Medical Unviersity

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

X

XU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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