NCT03104283

Brief Summary

The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2020

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

2.5 years

First QC Date

April 1, 2017

Last Update Submit

March 14, 2022

Conditions

Gastric Cancer

Keywords

apatinibgastric cancerelderly patients

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    PFS was defined to be the time from registration to the date of disease progress sion or death resulting from any cause.

    1 year

Secondary Outcomes (3)

  • Objective response rate (ORR)

    1 year

  • Disease control rate (DCR)

    1 year

  • Overall survival (OS)

    1 year

Study Arms (1)

Apatinib Group

EXPERIMENTAL

take apatinib orally (500mg/d or 250mg/d, once a day, continuously )

Drug: Apatinib

Interventions

ApatinibDRUG

take apatinib orally until disease progression or appearance of unbearable toxicity

Also known as: Apatinib group
Apatinib Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly patients (aged ≥ 60 years) with histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Progression with or intolerance to one or more lines of chemotherapy;
  • At least one measurable lesion as defined by RECIST 1.1;
  • With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
  • Can take apatinib orally;
  • Estimated life expectancy ≥ 3 months.

You may not qualify if:

  • Patients cannot take apatinib orally for any reason;
  • Patients with uncontrolled central nervous system (CNS) metastases;
  • Patients with massive hydrothorax or ascites;
  • Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
  • Newly-happened traumatism or pathological fracture;
  • Estimated life expectancy ˂ 3 months;
  • Received chemotherapy in the past 28 days before enrollment;
  • Patients with uncontrolled blood pressure on medication (≥ 140/90 mmHg);
  • Patients with bleeding tendency, receiving thrombolytics or anticoagulants, receiving intravenous antibiotic treatment, had received bevacizumab or other VEGF TKIs before, or with other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

Location

People's Hospital of Qinghai Province

Xining, Qinghai, 810000, China

Location

Qinghai Red Cross Hospital

Xining, Qinghai, 810000, China

Location

the Fifth People's Hospital of Qinghai Province

Xining, Qinghai, 810000, China

Location

Yangquan No.1 People's Hospital

Yangquan, Shanxi, 045000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jiuda Zhao, M.D.

    Affiliated Hospital of Qinghai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 7, 2017

Study Start

June 5, 2017

Primary Completion

December 1, 2019

Study Completion

June 2, 2020

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

CN(5)