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UNKNOWNPHASE2

S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)

Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma

NCT01533324•Second Military Medical University

Summary

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good efficiency and safety in colorectal cancer (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.

Detailed Description

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, 70 years \> Age \> 18 years
•Patient with unresectable primary hepatocellular carcinoma
•Child-Pugh Class A or B, without ascites
•ECOG score 0
•At least one tumor nodule can be evaluated by CT or MRI
•Can take medicine orally
•Expected survival time not less than 12 weeks
•Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception
•Patients must be:
•Hemoglobin \> 9.0g/dl
+9 more criteria

Exclusion Criteria

•Known or suspected allergy to any agent given in association with this trial
•Local treatment within 4 weeks prior to start of study drug
•History of any heart disease
•History of HIV infection except for HBV and HCV
•Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
•Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
•Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization within 6 months prior to study entry
•Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis and T1\], early gastric cancer, or other malignancies curatively treated \> 3 years prior to entry
•Extrahepatic tumor spread which affects patient's prognosis, such as bony metastasis or brain metastasis
•Hydrothorax， ascites and hydropericardium need to drain
+8 more criteria

Locations (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 1, 2011

Primary Completion Date

November 1, 2016

Completion Date

December 1, 2016

Last Updated

February 15, 2012

Enrollment

ESTIMATED participants

Conditions

CarcinomaLiver DiseasesHepatocellular Carcinoma

Interventions

S-1 combined with Leucovorin

DRUG

Contacts

Xie Feng, physician

CONTACT

+8613386272885 hunanxiefeng@yahoo.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria

Exclusion Criteria

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