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

NCT ID: NCT03334591

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Two Different Treatment Methods

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Apatinib 5 days' continuous use and 2 days' off

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

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Apatinib 500mg with Docetaxel 60mg/m2

Apatinib 500mg continuous use

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

Group Type ACTIVE_COMPARATOR

Apatinib

Intervention Type DRUG

Apatinib 500mg with Docetaxel 60mg/m2

Interventions

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Apatinib

Apatinib 500mg with Docetaxel 60mg/m2

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yifu He, doctor

Role: STUDY_CHAIR

Anhui Provincial Cancer Hospital

Locations

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Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yifu He, doctor

Role: CONTACT

Phone: 0551-65327666

Email: [email protected]

Facility Contacts

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yifu he, doctor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35280426 (View on PubMed)

Other Identifiers

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HYF001

Identifier Type: -

Identifier Source: org_study_id