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

NCT05871099 | Recruiting Phase 3 DMC

• 1 other identifier: HIPEC-09
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Advanced Gastric Cancer; HIPEC; Laparoscopic Gastrectomy; Randomized Clinical Trial; Recurrence-free survival

Outcome Measures

Primary Outcomes (1)

• 5-years Recurrence-free survival

  5 years

Secondary Outcomes (6)

• 5-year overall survival rate

  5 years

• peritoneal metastasis rate

  5 years

• peritoneal metastasis-free survival

  5 years

• Regional recurrence rate

  5 years

• distant metastasis rate

  5 years

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6\~8 cycles.

Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Control group

NO INTERVENTION

Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles

Interventions

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) PROCEDURE

Experimental group receive HIPEC two times after laproscopic gastrectomy

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Shandong Cancer Hospital and Institute: collaborator
• Chinese PLA General Hospital: collaborator
• Zibo Central Hospital: collaborator
• Jinan Central Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Shandong First Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Peking University People's Hospital: collaborator
• Tianjin Cancer Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Union Hospital of Huazhong University of Science and Technology: collaborator
• Brigham and Women's Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Weihai Municipal Hospital: collaborator
• Mountain University Cancer Hospital: collaborator
• Ruijin Hospital: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Zhongnan Hospital: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Yanbing Zhou, MD

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Central Study Contacts

Yanbing Zhou, MD

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Xiaodong Liu, MD

CONTACT

86532-82911324; miaozilxd@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 23, 2023
• Study Start: November 20, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)