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

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

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.

Study Overview

• Status: Terminated
• Conditions: Peritoneal Metastases From Gastric Cancer
• Intervention / Treatment: Procedure: exploratory laparoscopy or laparotomy; Procedure: HIPEC; Drug: Systemic chemotherapy; Drug: Apatinib

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Procedure: exploratory laparoscopy or laparotomy; Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery; Procedure: HIPEC; Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.; Drug: Systemic 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; Other Names: SOX; Drug: Apatinib; 500mg, once daily, day 1 to day 21.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 19, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Stomach Neoplasms; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: WuhanU_Peritoneal Metastases

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No