Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer
This trial is active, not recruiting.
|Treatments||s1+docetaxel, s1+docetaxel followed by s1|
|Sponsor||Hebei Tumor Hospital|
|Start date||October 2012|
|End date||December 2013|
|Trial size||100 participants|
|Trial identifier||NCT01718626, HBTH101|
Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency.
Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 1 years
Objective response rate(ORR)
time frame: 1 year
Disease control rate(DCR)
time frame: 1 year
time frame: 3 years
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Signed informed consent form - Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1 - Histologically or cytologically confirmed gastric cancer - Advanced or recurrent, metastatic disease - At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) - Life expectancy of at least 3 months - Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks - Haematopoietic and Hepatic status: Absolute neutrophil count >1.5x109/L,Platelet count > 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis) - Cardiovascular: Baseline LVEF 50% measured by echocardiography Exclusion Criteria: - Symptomatic brain metastasis - Active or uncontrolled infection - Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis - Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen - History of other malignancy - Pregnant or lactating women
|Principal investigator||Wei Liu|
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