NCT03349827

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

November 9, 2017

Last Update Submit

March 22, 2020

Conditions

Peritoneal Metastases From Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • radical resection rate

    The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases

    3 months

Secondary Outcomes (3)

  • the Peritoneal Cancer Index score

    3 months

  • overall survival

    3 years

  • complication rate

    3 years

Study Arms (1)

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 laparotomyProcedure: HIPECDrug: Systemic chemotherapyDrug: Apatinib

Interventions

exploratory laparoscopy or laparotomyPROCEDURE

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

Experimental
HIPECPROCEDURE

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

Experimental
Systemic chemotherapyDRUG

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

Also known as: SOX
Experimental
ApatinibDRUG

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

Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

LaparotomyHyperthermic Intraperitoneal ChemotherapyNeoadjuvant Therapyapatinib

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeChemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongnan Hospital

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 22, 2017

Study Start

January 5, 2018

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

CN(1)