Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02229058|
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Albumin Bound Paclitaxel Drug: S-1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: Albumin Bound Paclitaxel plus S-1
Abraxane 120 mg/m2, D1,D8;S-1 40~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
Drug: Albumin Bound Paclitaxel
120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.
Other Name: abraxane
40mg QD D1-D14,every 3 weeks,for BSA<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA>1.5m2,until disease progress or intolerable toxicity.
- Progression-free survival [ Time Frame: through study completion, an average of 2 years ]Progression-free survival is determined from the date of treatment to PD or death.
- Response rate [ Time Frame: up to one year ]the ratio of patients whose efficiency evaluation is CR or PR
- Overall survival [ Time Frame: OS follow-up period: 18 months or 80% OS events, whichever occurs first. ]the date of treatment to death from any cause or the last follow-up date
- Disease control rate [ Time Frame: AEs (Adverse events) should be recorded during the study period and six months after last IMP administration ]the ratio of patients whose efficiency evaluation is CR or PR or SD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229058
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Ruihua Xu, M.D,Ph.D||Sun Yat-sen University|