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

Phase 2

• Conditions: Gastric Cancer; Apatinib; Biomarker
• Interventions: Drug: Apatinib mesylate tablets

• Registration Number: NCT03219593
• Lead Sponsor: First Affiliated Hospital Bengbu Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Status Verified: 2017-09
• Study Start: 2017-09-07
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11
• Primary Completion: 2019-08
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib Group	Apatinib mesylate tablets	take apatinib orally (500mg/d, once a day, continuously)

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	1 year	PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years	OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.
Disease control rate (DCR)	1 year	DCR was defined as the proportion of patients who achieved complete response (CR ), partial response (PR) and stable disease (SD) for at least 8 weeks.
Objective response rate (ORR)	1 year	ORR was defined as the proportion of eligible patients who achieved a confirmed CR or PR by RECIST 1.1 criteria evaluated by the investigators.
Quality of life score (QoL)	1 year	QoL is a questionnaire developed to assess the quality of life of cancer patients.
Adverse Events(AEs)	1 year	AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Trial Locations

Locations (1)

Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China