NCT03889626

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_3

Status
unknown

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

March 17, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 17, 2019

Last Update Submit

March 23, 2019

Conditions

Stomach NeoplasmsGastrointestinal NeoplasmsStomach DiseasesDigestive System NeoplasmsCapecitabineApatinibNeoplasmsMolecular Mechanisms of Pharmacological Action

Keywords

CapecitabineApatinibMaintenance TreatmentAdvance Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS is calculated from the time of randmization to disease progression or death whichever happen first

    six weeks

Secondary Outcomes (1)

  • Overall Survival (OS)

    six weeks

Other Outcomes (2)

  • Quality of Life (QoL)

    six weeks

  • Adverse Events

    six weeks

Study Arms (3)

Apatinib

EXPERIMENTAL

In this arm, patients will receive a daily oral treatment with Apatinib 500mg.

Drug: Apatinib

Capecitabine

EXPERIMENTAL

In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.

Drug: Capecitabine

Observation

NO INTERVENTION

In this arm, no additional treatment will be given, and patients will be followed up at regular time

Interventions

ApatinibDRUG

Apatinib: 500mg qd po, q4w

Apatinib
CapecitabineDRUG

Capecitabine: 1000mg/m2 bid po, d1-14, q3w

Capecitabine

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsno younger than 18 year-old
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
  • ECOG PS 0-2
  • At least one measurable or evaluable lesion in the first-line chemotherapy
  • The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD
  • The time from the last cycle treatment to the enrollment cannot exceed 6 weeks
  • Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN)

You may not qualify if:

  • Received 2 or more regimens for palliative chemotherapy
  • Pregnant or lactating women
  • Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction
  • Clinically significant active bleeding, OB 2+ or higher
  • Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
  • Uncontrolled significant comorbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsGastrointestinal NeoplasmsStomach DiseasesDigestive System NeoplasmsNeoplasms

Interventions

apatinibCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Clinical Professor

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 26, 2019

Study Start

March 22, 2019

Primary Completion

March 22, 2022

Study Completion

March 22, 2024

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share