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

University of Science and Technology of China (USTC)

Status and phase: Unknown; Phase 2

Conditions: Two Different Treatment Methods

Treatments: Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03334591

HYF001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Apatinib 5 days' continuous use and 2 days' off

Experimental group

Description:

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

Treatment:

Drug: Apatinib

Apatinib 500mg continuous use

Active Comparator group

Description:

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

Treatment:

Drug: Apatinib