A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer
NCT ID: NCT02409199
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
66 participants
INTERVENTIONAL
2015-06-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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apatinib
Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
apatinib
Docetaxel
Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Docetaxel
Interventions
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Docetaxel
apatinib
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
* At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
* Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
* Life expectancy of more than 3 months;
* Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
* Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 109/L, neutrophil ≥1.5 × 109/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
Exclusion Criteria
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
* Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); Uncontrolled hypertension;
* Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
* Urine protein\>grade 1;
* Any factors that influence the usage of oral administration;
* patients with a clear tendency of gastrointestinal bleeding;
* Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
* Abuse of alcohol or drugs;
* Less than 4 weeks from the last clinical trial;
* Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
* Evidence of central nervous system(CNS) metastasis;
* Disability of serious uncontrolled intercurrence infection.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Tianshu Liu
Medicine-Oncology Derpartment of Zhongshan hospital
Principal Investigators
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Liu Tianshu, doctor
Role: PRINCIPAL_INVESTIGATOR
oncology department
Locations
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Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHEAD-G301
Identifier Type: -
Identifier Source: org_study_id