Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in
China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the
treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and
control group. In HIPEC group, the patients undergo radical gastrectomy with D2
lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the
control group just undergo radical gastrectomy with D2 lymphadenectomy followed by
postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative
systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.
Phase:
Phase 3
Details
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University Affiliated Tumor Hospital of Guangzhou Medical University
Collaborators:
Central South University Chinese PLA General Hospital Guangdong Provincial Hospital of Traditional Chinese Medicine Guangdong Provincial People's Hospital Harbin Medical University Hebei Medical University Fourth Hospital Henan Cancer Hospital Nanfang Hospital of Southern Medical University Sun Yat-sen University The Second Hospital of Hebei Medical University Tianjin Medical University Cancer Institute and Hospital Wuhan Union Hospital, China Zhejiang Cancer Hospital