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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring Advanced Gastric Cancer, HIPEC, Laparoscopic Gastrectomy, Randomized Clinical Trial, Recurrence-free survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Affiliated Hospital of Qingdao UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

5-years Recurrence-free survival

Secondary Outcome Measures

5-year overall survival rate
peritoneal metastasis rate
peritoneal metastasis-free survival
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
distant metastasis rate
Toxic and side effects of the program

Full Information

First Posted
May 14, 2023
Last Updated
May 14, 2023
Sponsor
The Affiliated Hospital of Qingdao University
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
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1. Study Identification

Unique Protocol Identification Number
NCT05871099
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
November 20, 2024 (Anticipated)
Study Completion Date
November 20, 2039 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Advanced Gastric Cancer, HIPEC, Laparoscopic Gastrectomy, Randomized Clinical Trial, Recurrence-free survival

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
616 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Intervention Description
Experimental group receive HIPEC two times after laproscopic gastrectomy
Primary Outcome Measure Information:
Title
5-years Recurrence-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
5-year overall survival rate
Time Frame
5 years
Title
peritoneal metastasis rate
Time Frame
5 years
Title
peritoneal metastasis-free survival
Time Frame
5 years
Title
Regional recurrence rate
Description
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
Time Frame
5 years
Title
distant metastasis rate
Time Frame
5 years
Title
Toxic and side effects of the program
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanbing Zhou, MD
Phone
86532-82911324
Email
zhouyanbing@qduhospital.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Liu, MD
Phone
86532-82911324
Email
miaozilxd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbing Zhou, MD
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Liu, MD
Phone
86532-82911324
Email
miaozilxd@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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