A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy
May 19, 2016 updated by: Tianjin Medical University Cancer Institute and Hospital
The main purpose of this study is to evaluate whether the Apatinib can improve the disease free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed postoprative adjuvant chemotherapy.
Meanwhile, the investigators also will evaluate whether the Apatinib can improve the overall survival (OS), estimate the quality of life of patients have taken the Apatinib and monitor the security of Apatinib.
Study Overview
Detailed Description
The investigators will recruit 40 gastric cancer patients who underwent D2 lymphadenectomy and histologically verified as stage ⅢB or ⅢC according to the seventh edition of the TNM classification for gastric cancer.
When these patients have completed 8 cycles of Xelox as adjuvant chemotherapy without any recurrence, they will randomly assigned to group A or B. Each group possesses 20 gastric cancer patients finally.
Patients in group A will receive the best supportive care，and take Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses.
Patients in group B will receive the best supportive care.
Through follow-up and statistics, the investigators will observe whether Apatinib can improve the disease free survival (DFS) of gastric cancer patients with stage IIIb&IIIC.
Meanwhile, the investigators also will observe whether the Apatinib can improve the overall survival (OS) and estimate the quality of life of patients have taken the Apatinib.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tianjin
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Tianjin, Tianjin, China, 300060
- Recruiting
- Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
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Contact:
- Liang Han, Master
- Phone Number: 1061 086-022-23340123
- Email: tjlianghan@126.com
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of patients ranges from 18 to75 years old.
- Score of the Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 2.
- All tumor tissues were histologically verified as advanced gastric cancer, and patients with no less than 15 dissected lymph nodes and stage of ⅢB or ⅢC according to TNM, were chosen.
- Gastric cancer patients underwent the curative gastrectomy with D2 lymphadenectomy.
- Gastric cancer patients received postoprative adjuvant chemotherapy of eight cycles of Xelox. During the period of chemotherapy, no one relapses. If the patients could well tolerate the adjuvant chemotherapy, it is recommended that patients can obtain maintenance treatment of Apatinib after postoprative adjuvant chemotherapy of eight cycles of Xelox.
- Previously, patients did not receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
- The blood examination is normal: neutrophil count≥1.5×109/L；hemoglobin≥80 g/L；blood platelet count≥100×109/L；total bilirubin≤1.5×ULN；ALT、AST≤2.5×ULN；
Patients have no serious heart, lung, liver, kidney diseases and jaundice and digestive tract obstruction. Patients have no an acute infection.
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Exclusion Criteria:
- The score of KPS<60 or anticipated survival time<3 months.
- Previously, patients received neoadjuvant chemotherapy.
- Within six months, patients encountered heart cerebral disease, got an uncontrolled hypertension (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg), had serious coronary heart disease, serious arrhythmia, first-grade cardiac insufficiency. Patients have positive urinary protein.
- Patients have clear gastrointestinal bleeding tendency, local active ulcer lesions, fecal occult blood (++); Patients have the symptoms of melena and haematemesis within 2 months.
- Coagulopathy (INR>1.5、APTT>1.5 ULN), hemorrhage tendency.
- Patients have these symptoms, such as dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction.
- Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
- Patients were pregnant, in nursing, or have bearing requirement during the study period.
- Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years.
- Patients have distant metastasis.
Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
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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 |
|---|---|
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Experimental: A group
D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox,and taking Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses.
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taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses
Other Names:
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No Intervention: B group
D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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disease free survival
Time Frame: 2 years
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Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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overall survival
Time Frame: 3 years
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Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Han Liang, Master, Tianjin Medical University Cancer Hospital
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
April 1, 2016
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
May 15, 2016
First Submitted That Met QC Criteria
May 15, 2016
First Posted (Estimate)
May 18, 2016
Study Record Updates
Last Update Posted (Estimate)
May 20, 2016
Last Update Submitted That Met QC Criteria
May 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHEAD-HBG001
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