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

Phase 2

• Conditions: Two Different Treatment Methods
• Interventions: Drug: Apatinib

• Registration Number: NCT03334591
• Lead Sponsor: Anhui Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-01
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
progress free survival(PFS)	1 year	From data of randomization until the date of first dccumentde progression or date of death from any cause

Secondary Outcome Measures

Name	Time	Method
disease control rate (DCR)	1year	investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor
Objective tumor response rate(ORR)	1year	difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments
overall survival (os)	1year	difined as the length of time from random assignment to death or to last contact
Quality of life score	1 year	a questionnaire developed to assess the quality of life of cancer patients
adverse events	1 year	adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events

Trial Locations

Locations (1)

Anhui Provincial Cancer Hospital; 🇨🇳 Hefei, Anhui, China