Clinical trial NCT05871099: Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
Official title: Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After Laparoscopic Gastrectomy With D2 Lymphadenectomy: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Advanced Gastric Cancer
HIPEC
Laparoscopic Gastrectomy
Randomized Clinical Trial
Recurrence-free survival
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
Collaborators: name: Shandong Cancer Hospital and Institute
name: Chinese PLA General Hospital
name: Zibo Central Hospital
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Jinan Central Hospital
name: Qilu Hospital of Shandong University
name: Yantai Yuhuangding Hospital
name: Nanfang Hospital, Southern Medical University
name: Shandong First Medical University
name: The First Affiliated Hospital of Nanchang University
name: Hebei Medical University Fourth Hospital
name: Peking University Cancer Hospital & Institute
name: Peking University People's Hospital
name: Tianjin Cancer Hospital
name: First Affiliated Hospital of Xi 'an Jiaotong University
name: Union Hospital of Huazhong University of Science and Technology
name: Wuhan University
name: Brigham and Women's Hospital
name: The Second Xiangya College of Central South University
name: Weihai Municipal Hospital
name: Mountain University Cancer Hospital
name: Ruijin Hospital
First posted: 2023-05-23
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: 5-years Recurrence-free survival
timeFrame: 5 years
Secondary outcomes:
measure: 5-year overall survival rate
timeFrame: 5 years
measure: peritoneal metastasis rate
timeFrame: 5 years
measure: peritoneal metastasis-free survival
timeFrame: 5 years
measure: Regional recurrence rate
timeFrame: 5 years
measure: distant metastasis rate
timeFrame: 5 years
measure: Toxic and side effects of the program
timeFrame: 5 years
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yanbing Zhou, MD
role: STUDY_DIRECTOR
References: