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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
China
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Contact Information
Primary
Yanbing Zhou, MD
zhouyanbing@qduhospital.cn
86532-82911324
Backup
Xiaodong Liu, MD
miaozilxd@163.com
86532-82911324
Time Frame
Start Date: 2022-11-20
Estimated Completion Date: 2039-11-20
Participants
Target number of participants: 616
Treatments
Experimental: Experimental group
Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6\~8 cycles.
No_intervention: Control group
Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, The First Affiliated Hospital of Nanchang University, Weihai Municipal Hospital, Ruijin Hospital, First Affiliated Hospital of Xi 'an Jiaotong University, Brigham and Women's Hospital, Shandong Cancer Hospital and Institute, Shandong First Medical University, Peking University Cancer Hospital & Institute, The Second Xiangya College of Central South University, Zibo Central Hospital, Peking University People's Hospital, Qilu Hospital of Shandong University, Mountain University Cancer Hospital, Tianjin Cancer Hospital, Nanfang Hospital, Southern Medical University, Jinan Central Hospital, Yantai Yuhuangding Hospital, Chinese PLA General Hospital, Wuhan University, Union Hospital of Huazhong University of Science and Technology, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Leads: The Affiliated Hospital of Qingdao University

This content was sourced from clinicaltrials.gov