Back to resultsThe Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Apatinib
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Capecitabine, Apatinib, Maintenance Treatment, Advance Gastric Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Apatinib
Capecitabine
Observation
Arm Description
In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
In this arm, no additional treatment will be given, and patients will be followed up at regular time
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
PFS is calculated from the time of randmization to disease progression or death whichever happen first
Secondary Outcome Measures
Overall Survival (OS)
OS is calculated from the time of randmization to death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03889626
Brief Title
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer
Official Title
A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 22, 2019 (Anticipated)
Primary Completion Date
March 22, 2022 (Anticipated)
Study Completion Date
March 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Gastrointestinal Neoplasms, Stomach Diseases, Digestive System Neoplasms, Capecitabine, Apatinib, Neoplasms, Molecular Mechanisms of Pharmacological Action
Keywords
Capecitabine, Apatinib, Maintenance Treatment, Advance Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib
Arm Type
Experimental
Arm Description
In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
In this arm, no additional treatment will be given, and patients will be followed up at regular time
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib: 500mg qd po, q4w
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine: 1000mg/m2 bid po, d1-14, q3w
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is calculated from the time of randmization to disease progression or death whichever happen first
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is calculated from the time of randmization to death
Time Frame
six weeks
Other Pre-specified Outcome Measures:
Title
Quality of Life (QoL)
Description
we will use EORTC QLQ-C30 to evaluate QoL.
Time Frame
six weeks
Title
Adverse Events
Description
we will use CTC AE4.0 to evaluate adverse events.
Time Frame
six weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
no younger than 18 year-old
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer
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