The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

March 23, 2019 updated by: Xiaodong Zhu, Fudan University

A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

Study Type

Interventional

Enrollment (Anticipated)

242

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib
In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
Drug: Apatinib
Apatinib: 500mg qd po, q4w
Experimental: Capecitabine
In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
Drug: Capecitabine
Capecitabine: 1000mg/m2 bid po, d1-14, q3w
No Intervention: Observation
In this arm, no additional treatment will be given, and patients will be followed up at regular time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: six weeks
PFS is calculated from the time of randmization to disease progression or death whichever happen first
six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: six weeks
OS is calculated from the time of randmization to death
six weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: six weeks
we will use EORTC QLQ-C30 to evaluate QoL.
six weeks
Adverse Events
Time Frame: six weeks
we will use CTC AE4.0 to evaluate adverse events.
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 22, 2019

Primary Completion (Anticipated)

March 22, 2022

Study Completion (Anticipated)

March 22, 2024

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 23, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apa/Cap maintenance in GC

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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