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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871099
• Other study ID #: HIPEC-09
• Status: Recruiting
• Phase: Phase 3
• Start date: November 20, 2022
• Est. completion date: November 20, 2039

Study information

• Verified date: May 2023
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yanbing Zhou, MD
• Phone: 86532-82911324
• Email: zhouyanbing[@]qduhospital.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: November 20, 2039
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Experimental group receive HIPEC two times after laproscopic gastrectomy

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (23)

Lead Sponsor

Collaborator

The Affiliated Hospital of Qingdao University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-years Recurrence-free survival		5 years
Secondary	5-year overall survival rate		5 years
Secondary	peritoneal metastasis rate		5 years
Secondary	peritoneal metastasis-free survival		5 years
Secondary	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
Secondary	distant metastasis rate		5 years
Secondary	Toxic and side effects of the program		5 years