- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889626
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.
|
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.
|
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
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Diseases
- Neoplasms
- Stomach Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Stomach Diseases
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Capecitabine
- Apatinib
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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