Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

Phase 2

Recruiting

• Conditions: Malignant Neoplasm of Stomach
• Interventions: Procedure: D2 radical gastrectomy; Drug: SOX neoadjuvant or postoperative chemotherapy; Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)

• Registration Number: NCT04345770
• Lead Sponsor: Wuhan University

Brief Summary

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.

Detailed Description

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open and parallel group study.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-01
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Histological proved diagnosis of locally advanced gastric cancer.
• No evidence of distant metastases or peritoneal metastases.
• Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
• Eligible for radical gastrectomy with D2 lymphadenectomy.
• Have not received cytotoxic chemotherapy or radiotherapy.
• Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria

• Existence of distant metastasis or peritoneal metastasis during surgery (M1).
• Any previous chemotherapy or radiotherapy
• Active systemic infections
• Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
• Female patients who are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With HIPEC	D2 radical gastrectomy	Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
With HIPEC	SOX neoadjuvant or postoperative chemotherapy	Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
Without HIPEC	SOX neoadjuvant or postoperative chemotherapy	Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
Without HIPEC	D2 radical gastrectomy	Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
With HIPEC	Hyperthermic intraperitoneal chemotherapy (HIPEC)	Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)

Primary Outcome Measures

Name	Time	Method
overall survival	5 years	From the date of surgery to the date of death or to the end of follow-up

Secondary Outcome Measures

Name	Time	Method
peritoneal metastasis rate	5 years
distant metastasis rate	5 years
local recurrence rate	5 years
complication rate	5 years
progression-free survival	5 years

Trial Locations

Locations (1)

Wuhan University; 🇨🇳 Wuhan, Hubei, China