Peritoneal Metastases From Gastric Cancer
Conditions
Brief summary
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.
Detailed description
To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer, patients undergo 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.
Interventions
Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery
PROCEDUREHIPEC
Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.
DRUGSystemic chemotherapy
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
DRUGApatinib
500mg, once daily, day 1 to day 21.
Sponsors
Wuhan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological proved diagnosis of gastric cancer. * Unresectable peritoneal metastases and primary tumor proved at surgery. * No evidence of distant metastases. * Have not received radiotherapy, chemotherapy or immunotherapy. * ECOG score: 0\ 2. * Written informed consent is obtained prior to commencement of trial treatment.
Exclusion criteria
* Existence of distant metastasis outside the abdomen. * Any previous radiotherapy, chemotherapy or immunotherapy. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radical resection rate | 3 months | The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Peritoneal Cancer Index score | 3 months | The score range from 0 to 39, higher values represent a worse outcome |
| overall survival | 3 years | The overall survival time |
| complication rate | 3 years | The rate of adverse complication |
Countries
China
Outcome results
None listed