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

A Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Apatinib; Biomarker
• Intervention / Treatment: Drug: Apatinib mesylate tablets

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yan Yang, M.D.,Ph.D; Phone Number: +86-552-3086178; Email: qiannianhupo@163.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Apatinib Group; take apatinib orally (500mg/d, once a day, continuously)

Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.	2 years
Disease control rate (DCR)	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.	1 year
Objective response rate (ORR)	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.	1 year
Quality of life score (QoL)	QoL is a questionnaire developed to assess the quality of life of cancer patients.	1 year
Adverse Events(AEs)	AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor biomarkers	Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling.	Before the start of apatinib treatment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Bengbu Medical College
• Investigators: Principal Investigator: Qiong Wu, M.D.,Ph.D, First Affiliated Hospital of Bengbu Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: BYEC20170710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No