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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

NCT02549911.

Trial name or title Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis
Methods Phase 2
Intervention Model: Single‐group assignment
Masking: Open‐label
Primary Purpose: Treatment
Participants N = 40
18‐75 years
Gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.
Interventions Experimental: HIPEC,Chemotherapy AND surgery
  1. Surgical exploration,if PCI < 20,then we perform this study

  2. HIPEC(RHL‐2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m² , twice, within 72 hours after surgical exploration ; oral chemotherapy:S‐1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80 mg/m², twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.

  3. Chemotherapy (3 cycles) : Taxol 150 mg/m² ,d 1, S‐1: 80 mg/m², twice daily (after breakfast and supper) for two weeks, and then suspend for one week.

  4. Surgery: Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumours and metastases )

  5. after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles


Intervention: Other: HIPEC, chemotherapy AND surgery
Outcomes R0 resection [Time frame: 3 months]
Adverse events [Time frame: 6 months]
Overall survival time [Time Frame: 3 years]
Starting date September 2015
Contact information Yian Du, MD; ypfzmu@163.com; 86‐571‐88128031
Notes