Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

• Study Type: Interventional
• Enrollment (Estimated): 616
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yanbing Zhou, MD; Phone Number: 86532-82911324; Email: zhouyanbing@qduhospital.cn
• Study Contact Backup: Name: Xiaodong Liu, MD; Phone Number: 86532-82911324; Email: miaozilxd@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • The affiliated hospital of Qingdao university
      • Contact: Xiaodong Liu, MD; Phone Number: 86532-82911324; Email: miaozilxd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles.	Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC); Experimental group receive HIPEC two times after laproscopic gastrectomy
No Intervention: Control group; Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
5-years Recurrence-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
distant metastasis rate		5 years
peritoneal metastasis rate		5 years
5-year overall survival rate		5 years
peritoneal metastasis-free survival		5 years
Regional recurrence rate	local recurrence after radical gastrectomy refers to the recurrence of anastomosis, duodenal stump, tumor bed, and residual stomach, including the recurrence of regional lymph nodes	5 years
Toxic and side effects of the program		5 years

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Collaborators: The First Affiliated Hospital of Nanchang University; Peking University People's Hospital; Brigham and Women's Hospital; Chinese PLA General Hospital; Qilu Hospital of Shandong University; Peking University Cancer Hospital & Institute; First Affiliated Hospital Xi'an Jiaotong University; Ruijin Hospital; Shandong Cancer Hospital and Institute; Zhongnan Hospital; Hebei Medical University Fourth Hospital; Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Jinan Central Hospital; Second Xiangya Hospital of Central South University; Yantai Yuhuangding Hospital; Zibo Central Hospital; Weihai Municipal Hospital; Shandong First Medical University; Tianjin Cancer Hospital; Union Hospital of Huazhong University of Science and Technology; Mountain University Cancer Hospital; Nanfang Hospital, Southern Medical University
• Investigators: Study Director: Yanbing Zhou, MD, The affiliated hospital of Qingdao university

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIPEC; Laparoscopic Gastrectomy; Randomized Clinical Trial; Advanced Gastric Cancer; Recurrence-free survival
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Therapeutics; Drug Therapy; Hyperthermia, Induced; Combined Modality Therapy; Chemotherapy, Adjuvant; Hyperthermic Intraperitoneal Chemotherapy
• Other Study ID Numbers: HIPEC-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No