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

NCT ID: NCT03349827

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2020-03-20

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.

Conditions

Peritoneal Metastases From Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

exploratory laparoscopy or laparotomy

Intervention Type: PROCEDURE

Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery

HIPEC

Intervention Type: PROCEDURE

Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.

Systemic chemotherapy

Intervention Type: 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

Intervention Type: DRUG

500mg, once daily, day 1 to day 21.

Interventions

exploratory laparoscopy or laparotomy

Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery

Intervention Type: PROCEDURE

HIPEC

Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Apatinib

500mg, once daily, day 1 to day 21.

Intervention Type: DRUG

Other Intervention Names

SOX

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Bin Xiong, MD

Zhongnan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

WuhanU_Peritoneal Metastases

Identifier Type: -

Identifier Source: org_study_id