This trial is active, not recruiting.

Condition gastric cancer
Treatments s1+docetaxel, s1+docetaxel followed by s1
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression
s1+docetaxel followed by s1
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression

Primary Outcomes

Progression-free survival(PFS)
time frame: 1 years

Secondary Outcomes

Objective response rate(ORR)
time frame: 1 year
Disease control rate(DCR)
time frame: 1 year
Overall survival(OS)
time frame: 3 years

Eligibility Criteria

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

Additional Information

Principal investigator Wei Liu
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Hebei Tumor Hospital.