Actively Recruiting
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
Led by The Affiliated Hospital of Qingdao University · Updated on 2026-03-06
616
Participants Needed
1
Research Sites
419 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Qingdao University
Lead Sponsor
S
Shandong Cancer Hospital and Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer after Laparoscopic Gastrectomy with D2 Lymphadenectomy. The main question it aims to answer is: whether HIPEC can effectively improving the 5-year overall survival rate and decrease the peritoneal metastases rate of patients with advanced gastric cancer underwent Laparoscopic Gastrectomy with D2 Lymphadenectomy. Participants will be divided into two groups, Experimental group received laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6\~8 cycles; and Control group received laparoscopic (robotic) D2 surgery plus systemic chemotherapy 6\~8 cycles.
CONDITIONS
Official Title
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly treated patients who have not received chemotherapy, radiotherapy, or other antitumor therapy before the trial
- Aged 18 to 80 years
- Male or non-pregnant, non-lactating female
- Pathologically confirmed gastric adenocarcinoma with planned laparoscopic (robotic) radical gastrectomy
- Tumor stage T3 or above without distant metastasis and suitable for laparoscopic D2 radical resection (AJCC Eighth edition)
- Estimated survival time of more than 6 months
- History of non-abdominal surgery (except laparoscopic cholecystectomy)
- Good bone marrow function with white blood cell count ≥3.5×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L
- Good organ function with ALT ≤2.5× upper limit of normal, AST ≤2.5× upper limit of normal, serum total bilirubin ≤1.5× upper limit of normal, serum creatinine ≤1.5× upper limit of normal
- Functional status ECOG 0-1
- Preoperative ASA grade I-III
- Voluntarily signed informed consent
You will not qualify if you...
- Lymph node BulkyN2 diagnosed by abdominal CT/MRI with at least one lymph node ≥3 cm or three consecutive lymph nodes each ≥1.5 cm
- Pregnant or lactating women
- Other malignant tumors within the past 5 years
- Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment
- Serious mental illness
- Severe respiratory diseases with FEV1 < 50%
- Severe liver and kidney dysfunction, liver enzyme elevation more than twice normal value
- History of unstable angina or myocardial infarction within 6 months
- History of cerebral infarction or hemorrhage within 6 months, except old infarct
- Systemic glucocorticoid therapy within 1 month
- Gastric cancer complications requiring emergency surgery (bleeding, perforation, obstruction)
- Participation in other clinical studies within 6 months
- Intraperitoneal implantation and metastasis confirmed by laparoscopic exploration, biopsy, and cytology
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
Research Team
Y
Yanbing Zhou, MD
CONTACT
X
Xiaodong Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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