Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Wuhan University
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Updated on 7 May 2025
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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.

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.

Details
Condition Malignant Neoplasm of Stomach
Age 18years - 75years
Clinical Study IdentifierNCT04345770
SponsorWuhan University
Last Modified on7 May 2025

Eligibility

 Yes No Not Sure

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
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