Trial Title:
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
NCT ID:
NCT05871099
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Advanced Gastric Cancer
HIPEC
Laparoscopic Gastrectomy
Randomized Clinical Trial
Recurrence-free survival
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Description:
Experimental group receive HIPEC two times after laproscopic gastrectomy
Arm group label:
Experimental group
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
(1) Newly treated patients who did not receive chemotherapy, radiotherapy or other
antitumor therapy before the start of the clinical trial;(2) Aged 18-80 years;(3) male or
non-pregnant or lactating female;(4) Gastric adenocarcinoma was pathologically confirmed,
and laparoscopic (robotic) radical gastrectomy was planned;(5) Patients with T stage T3
or above, no distant metastasis, and feasible criteria for laparoscopic D2 radical
resection (AJCC Eighth edition);(6) The estimated survival time is more than 6 months;(7)
History of nonabdominal surgery (except laparoscopic cholecystectomy);(8) The bone marrow
reserve function was good, and the blood routine met the following conditions: white
blood cell count ≥3.5×109/L, neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin
≥90g/L;(9) Organ function was good, and biochemical examination met the following
conditions: ALT≤2.5× upper limit of normal value (ULN), AST≤2.5×ULN, serum total
bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;(10) Functional status: 0-1 (ECOG);(11)
Preoperative ASA grade I-III;(12) Voluntarily sign the informed consent.
Exclusion Criteria:
(1) Lymph node BulkyN2 status was diagnosed by abdominal CT/MRI, that is, at least one
lymph node meridian ≥3cm or three consecutive lymph nodes, each meridian ≥1.5cm;(2)
pregnant or lactating women;(3) Other malignant tumors within 5 years;(4) Preoperative
temperature ≥38℃ or complicated with infectious diseases requiring systematic
treatment;(5) serious mental illness;(6) Severe respiratory diseases, FEV1< 50%;(7)
Severe liver and kidney dysfunction, liver enzyme elevation more than 2 times the normal
value;(8) History of unstable angina pectoris or myocardial infarction within 6
months;(9) History of cerebral infarction or cerebral hemorrhage within 6 months, except
old infarct;(10) Systemic glucocorticoid therapy within 1 month;(11) Patients with
gastric cancer complications (bleeding, perforation, obstruction) requiring emergency
surgery;(12) The patient has participated in or is currently participating in other
clinical studies (within 6 months);(13) Laparoscopic exploration, biopsy and cytology
confirmed intraperitoneal implantation and metastasis.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaodong Liu, MD
Phone:
86532-82911324
Email:
miaozilxd@163.com
Start date:
November 20, 2022
Completion date:
November 20, 2039
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
Zibo Central Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Jinan Central Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Yantai Yuhuangding Hospital
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Provincial Hospital Affiliated to Shandong First Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Xi 'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Union Hospital of Huazhong University of Science and Technology
Agency class:
Other
Collaborator:
Agency:
Wuhan University
Agency class:
Other
Collaborator:
Agency:
Brigham and Women's Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Xiangya College of Central South University
Agency class:
Other
Collaborator:
Agency:
Weihai Municipal Hospital
Agency class:
Other
Collaborator:
Agency:
Mountain University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871099
