Back to resultsHIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer
Primary Purpose
Peritoneal Metastases From Gastric Cancer
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
exploratory laparoscopy or laparotomy
HIPEC
Systemic chemotherapy
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Metastases From Gastric Cancer
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
Sites / Locations
- Wuhan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
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.
Outcomes
Primary Outcome Measures
radical resection rate
The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases
Secondary Outcome Measures
the Peritoneal Cancer Index score
The score range from 0 to 39, higher values represent a worse outcome
overall survival
The overall survival time
complication rate
The rate of adverse complication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03349827
Brief Title
HIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
No enrolled patients received the second surgery.
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Metastases From Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
exploratory laparoscopy or laparotomy
Intervention Description
Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery
Intervention Type
Procedure
Intervention Name(s)
HIPEC
Intervention Description
Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.
Intervention Type
Drug
Intervention Name(s)
Systemic chemotherapy
Other Intervention Name(s)
SOX
Intervention Description
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
Intervention Name(s)
Apatinib
Intervention Description
500mg, once daily, day 1 to day 21.
Primary Outcome Measure Information:
Title
radical resection rate
Description
The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases
Time Frame
3 months
Secondary Outcome Measure Information:
Title
the Peritoneal Cancer Index score
Description
The score range from 0 to 39, higher values represent a worse outcome
Time Frame
3 months
Title
overall survival
Description
The overall survival time
Time Frame
3 years
Title
complication rate
Description
The rate of adverse complication
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
12. IPD Sharing Statement
Learn more about this trial
HIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer
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