Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2017
1 active site
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
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 14, 2017
October 1, 2017
2 years
November 3, 2017
November 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
progress free survival(PFS)
From data of randomization until the date of first dccumentde progression or date of death from any cause
1 year
Secondary Outcomes (5)
disease control rate (DCR)
1year
Objective tumor response rate(ORR)
1year
overall survival (os)
1year
Quality of life score
1 year
adverse events
1 year
Study Arms (2)
Apatinib 5 days' continuous use and 2 days' off
EXPERIMENTALApatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer
Apatinib 500mg continuous use
ACTIVE COMPARATORApatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer
Interventions
Apatinib 500mg with Docetaxel 60mg/m2
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Related Publications (1)
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.
PMID: 35280426DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
yifu He, doctor
Anhui Provincial Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2017
First Posted
November 7, 2017
Study Start
October 1, 2017
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
November 14, 2017
Record last verified: 2017-10