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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

    Procedure/Surgery

    Experimental group receive HIPEC two times after laproscopic gastrectomy

Treatment groups

616 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

5-years Recurrence-free survival

Time frame
5 years

Secondary outcomes

1

5-year overall survival rate

Time frame
5 years
2

peritoneal metastasis rate

Time frame
5 years
3

peritoneal metastasis-free survival

Time frame
5 years
4

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Hospital of Qingdao University

Lead sponsor

Shandong Cancer Hospital and Institute

Collaborator

Chinese PLA General Hospital

Collaborator

Zibo Central Hospital

Collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Collaborator

Jinan Central Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Yantai Yuhuangding Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Shandong First Medical University

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Peking University People's Hospital

Collaborator

Tianjin Cancer Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Zhongnan Hospital

Collaborator

Brigham and Women's Hospital

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Weihai Municipal Hospital

Collaborator

Mountain University Cancer Hospital

Collaborator

Ruijin Hospital

Collaborator