HIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer

Sponsor
Wuhan University
Study ID
NCT03349827
Status
Terminated

Conditions

  • Peritoneal Metastases From Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • exploratory laparoscopy or laparotomy — PROCEDURE
    Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery
  • HIPEC — PROCEDURE
    Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.
  • Systemic chemotherapy — DRUG
    Oxaliplatin: 130mg/m2, day 1. S1: 60mg, twice daily, day 1 to day 14. S1:60mg twice daily for two weeks, and then suspend for one week
  • Apatinib — DRUG
    500mg, once daily, day 1 to day 21.

Study Details

The prognosis of patients with unresectable peritoneal metastases from gastric cancer is poor. These patients may obtain survival benefit from radical gastrectomy and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with gastric cancer. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer.

Key Dates

Start date
Jan 5, 2018
Status verified
Mar 2020
Primary completion
Mar 20, 2020
Completion
Mar 20, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    HIPEC with Docetaxel/ Lobaplatin at the time of fist surgery and twice repeat within one week after the surgery, following 2 cycles of 3-week Oxaliplatin/S1 chemotherapy combined with Apatinib and 1 cycles of 3-week Oxaliplatin/S1 chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Primary Outcome Measure

radical resection rate [ Time Frame: 3 months ]