S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)
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|ClinicalTrials.gov Identifier: NCT01533324|
Recruitment Status : Unknown
Verified February 2012 by Xie feng, Second Military Medical University.
Recruitment status was: Recruiting
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma Liver Diseases Hepatocellular Carcinoma||Drug: S-1 combined with Leucovorin||Phase 2|
S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in CRC. The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.
SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: S-1 combined with LV
S-1 combined with LV
Drug: S-1 combined with Leucovorin
S-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off
- DCR [ Time Frame: in two years ]DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
- TTP ( time to progression) [ Time Frame: in 2 years ]from enrolled to progression(iconography).
- OS ( overall survival) [ Time Frame: in two years ]to death
- safety [ Time Frame: in two years ]any adverse reaction by NCI-CTCAE 3.0
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): NCT01533324
|Contact: Xie Feng, firstname.lastname@example.org|
|Eastern Hepatobiliary Surgery Hospital||Recruiting|
|Shanghai, Shanghai, China, 200438|
|Contact: Xie Feng, attending physician +8613386272885 email@example.com|
|Principal Investigator: Xie Feng, attending physician|
|Study Chair:||Yang Jiamei, Chief||Second Military Medical University|