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Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer

Primary Purpose

Two Different Treatment Methods

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
Anhui Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Two Different Treatment Methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female patients,age≥18years
  2. Confirmed by Pathology or histology of Gastric cancer
  3. Patients who failed first-line chemotherapy
  4. The ECOG physical status score:0 to 2
  5. Expected survival ≥3months
  6. Patients should be voluntary to the trail and provide with signed informed consent.
  7. The researchers believe patients can benefit from the study.

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories
  3. Patients with apatinib contraindications
  4. Patients of doctors considered unsuitable for the trail

Sites / Locations

  • Anhui Provincial Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apatinib 5 days' continuous use and 2 days' off

Apatinib 500mg continuous use

Arm Description

Apatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer

Apatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer

Outcomes

Primary Outcome Measures

progress free survival(PFS)
From data of randomization until the date of first dccumentde progression or date of death from any cause

Secondary Outcome Measures

disease control rate (DCR)
investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor
Objective tumor response rate(ORR)
difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments
overall survival (os)
difined as the length of time from random assignment to death or to last contact
Quality of life score
a questionnaire developed to assess the quality of life of cancer patients
adverse events
adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events

Full Information

First Posted
November 3, 2017
Last Updated
November 13, 2017
Sponsor
Anhui Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03334591
Brief Title
Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
Official Title
Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital

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 investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Two Different Treatment Methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib 5 days' continuous use and 2 days' off
Arm Type
Experimental
Arm Description
Apatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer
Arm Title
Apatinib 500mg continuous use
Arm Type
Active Comparator
Arm Description
Apatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib 500mg with Docetaxel 60mg/m2
Primary Outcome Measure Information:
Title
progress free survival(PFS)
Description
From data of randomization until the date of first dccumentde progression or date of death from any cause
Time Frame
1 year
Secondary Outcome Measure Information:
Title
disease control rate (DCR)
Description
investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor
Time Frame
1year
Title
Objective tumor response rate(ORR)
Description
difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments
Time Frame
1year
Title
overall survival (os)
Description
difined as the length of time from random assignment to death or to last contact
Time Frame
1year
Title
Quality of life score
Description
a questionnaire developed to assess the quality of life of cancer patients
Time Frame
1 year
Title
adverse events
Description
adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients,age≥18years Confirmed by Pathology or histology of Gastric cancer Patients who failed first-line chemotherapy The ECOG physical status score:0 to 2 Expected survival ≥3months Patients should be voluntary to the trail and provide with signed informed consent. The researchers believe patients can benefit from the study. Exclusion Criteria: Pregnant or lactating women Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories Patients with apatinib contraindications Patients of doctors considered unsuitable for the trail
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yifu He, doctor
Phone
0551-65327666
Email
834638033@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yifu He, doctor
Organizational Affiliation
Anhui Provincial Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yifu he, doctor
Phone
0551-65327666
Email
834638033@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35280426
Citation
Yan Y, Li H, Wu S, Wang G, Luo H, Niu J, Cao L, Hu X, Xu H, Jia W, Sun Y, Yao Y, Chen W, Ke L, Hu B, Ji C, Sun Y, Chen J, Li M, He Y. Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study. Ann Transl Med. 2022 Feb;10(4):205. doi: 10.21037/atm-22-546.
Results Reference
derived

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Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer

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