Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer

NCT ID: NCT03219593

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2020-02-29

Brief Summary

The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.

Conditions

Gastric Cancer; Apatinib; Biomarker

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib Group

take apatinib orally (500mg/d, once a day, continuously)

Group Type: EXPERIMENTAL

Apatinib mesylate tablets

Intervention Type: DRUG

Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.

Interventions

Apatinib mesylate tablets

Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;

2. Age ≥ 65 years;

3. ECOG Performance Status: 0-2;

4. No previous anti-cancer therapy for the locally advanced or metastatic disease;

5. Unable or unwilling to chemotherapy;

6. At least one measurable lesion as defined by RECIST 1.1;

7. With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;

8. Can take apatinib orally;

9. Life Expectancy: 3 months or more.

Exclusion Criteria

1. History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);

2. Patients with un-controlled blood pressure on medication (> 140/90 mmHg);

3. Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;

4. Patients with bleeding tendency, receiving thrombolytics or anticoagulants；

5. Patients with massive hydrothorax or ascites;

6. Patients with uncontrolled central nervous system (CNS) metastases;

7. Proteinuria 2+ or 24-hour urinary protein ≥ 1g;

8. History of drug addiction or abuse;

9. Patients cannot take apatinib orally for any reason;

10. Estimated life expectancy ˂ 3 months;

11. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;

12. Inability to understand and agree to informed consent.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Wu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Wu, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Bengbu Medical College

Locations

Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Yang, M.D.,Ph.D

Role: CONTACT

qiannianhupo@163.com

+86-552-3086178

Facility Contacts

Yan Yang, M.D., Ph.D.

Role: primary

qiannianhupo@163.com

+86-552-3086178

Other Identifiers

BYEC20170710

Identifier Type: -

Identifier Source: org_study_id