Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2

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.

Conditions

• Gastric Cancer

Interventions

PROCEDURE

D2 lymphadenectomy

PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy

The first HIPEC is conducted within 48 h after surgery: Normal saline 3000 -4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.

DRUG

Systemic chemotherapy (XELOX or SOX regimens)

XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles. SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Harbin Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

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

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  lead OTHER

Principal Investigators

• shuzhong cui, M.D · Affiliated Tumor Hospital of Guangzhou Medical University Recruiting

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-11

Primary Completion

2022-01-31

Completion

2022-01-31

Countries

• China

Study Locations