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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/S1 Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer

Conditions
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Peritoneal Metastases From Gastric Cancer

Intervention / Treatment
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* Procedure: exploratory laparoscopy or laparotomy
* Procedure: HIPEC
* Drug: Systemic chemotherapy
* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Procedure: exploratory laparoscopy or laparotomy<br>* Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery<br>Procedure: HIPEC<br>* Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.<br>Drug: Systemic chemotherapy<br>* 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<br>* Other names: SOX;Drug: Apatinib<br>* 500mg, once daily, day 1 to day 21.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radical resection rate | The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Peritoneal Cancer Index score | The score range from 0 to 39, higher values represent a worse outcome | 3 months | 
| overall survival | The overall survival time | 3 years | 
| complication rate | The rate of adverse complication | 3 years |