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

• ClinicalTrials.gov Identifier: NCT05871099
• Recruitment Status: Recruiting
• First Posted: May 23, 2023
• Last Update Posted: May 23, 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
• Information provided by (Responsible Party): The Affiliated Hospital of Qingdao University

Tracking Information

• First Submitted Date: May 14, 2023
• First Posted Date: May 23, 2023
• Last Update Posted Date: May 23, 2023
• Actual Study Start Date: November 20, 2022
• Estimated Primary Completion Date: November 20, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 14, 2023): 5-years Recurrence-free survival [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 14, 2023)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Gastric Cancer

Intervention

Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Experimental group receive HIPEC two times after laproscopic gastrectomy

Study Arms

• Experimental: Experimental group
  Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles.
  Intervention: Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
• No Intervention: Control group
  Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 14, 2023): 616
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 20, 2039
• Estimated Primary Completion Date: November 20, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Yanbing Zhou, MD; 86532-82911324; zhouyanbing@qduhospital.cn

Contact: Xiaodong Liu, MD; 86532-82911324; miaozilxd@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05871099
• Other Study ID Numbers: HIPEC-09
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)

• Current Responsible Party: The Affiliated Hospital of Qingdao University
• Original Responsible Party: Same as current
• Current Study Sponsor: The Affiliated Hospital of Qingdao University
• Original Study Sponsor: Same as current

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

Investigators

• Study Director: Yanbing Zhou, MD; The Affiliated Hospital of Qingdao University

• PRS Account: The Affiliated Hospital of Qingdao University
• Verification Date: May 2023