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

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ClinicalTrials.gov Identifier: NCT05871099

Recruitment Status : Recruiting

First Posted : May 23, 2023

Last Update Posted : May 23, 2023

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Sponsor:

Collaborators:

Shandong Cancer Hospital Affiliated to Shandong First Medical University

Chinese PLA General Hospital

Zibo Central Hospital

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Jinan Central Hospital

Qilu Hospital of Shandong University

Yantai Yuhuangding Hospital

Nanfang Hospital, Southern Medical University

Provincial Hospital Affiliated to Shandong First Medical University

The First Affiliated Hospital of Nanchang University

The Fourth Hospital of Hebei Medical University

Peking University Cancer Hospital & Institute

Peking University People's Hospital

Tianjin Cancer Hospital

First Affiliated Hospital of Xi 'an Jiaotong University

Union Hospital of Huazhong University of Science and Technology

Wuhan University

Brigham and Women's Hospital

The Second Xiangya College of Central South University

Weihai Municipal Hospital

Mountain University Cancer Hospital

Ruijin Hospital

Information provided by (Responsible Party):

The Affiliated Hospital of Qingdao University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	616 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Actual Study Start Date :	November 20, 2022
Estimated Primary Completion Date :	November 20, 2024
Estimated Study Completion Date :	November 20, 2039

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Stomach Cancer

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

5-years Recurrence-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :

5-year overall survival rate [ Time Frame: 5 years ]
peritoneal metastasis rate [ Time Frame: 5 years ]
peritoneal metastasis-free survival [ Time Frame: 5 years ]
Regional recurrence rate [ Time Frame: 5 years ]
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
distant metastasis rate [ Time Frame: 5 years ]
Toxic and side effects of the program [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations