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

NCT ID: NCT01533324

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-12-31

Brief 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).

Conditions

Carcinoma; Liver Diseases; Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1 combined with LV

S-1 combined with LV

Group Type: EXPERIMENTAL

S-1 combined with Leucovorin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

TS-1; formyltetrahydrofolate

Eligibility Criteria

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
• ANC > 1.5×109/L
• Platelet ≥ 60×109/L
• Total bilirubin < 3mg/dl
• ALT or AST < 5 X ULN
• ALP < 4 X ULN
• PT-INR < 2.3
• Patients who is taking Warfarin , should be tested every week till getting stable INR
• Serum creatinine < 1.5 X ULN
• Serum amylase and lipase < 2 X ULN

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
• Serious diarrhea
• Combined with serious pulmonary diseases, such as interstitial pneumonia, pulmonary fibrosis and serious pulmonary emphysema
• Serious complication,such as intestinal obstruction,renal insufficiency, hepatic insufficiency and cerebrovascular disorders
• Pregnant or breast-feeding
• Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
• Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
• Patients unable to swallow oral medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xie feng

attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Jiamei, Chief

Role: STUDY_CHAIR

Second Military Medical University

Locations

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xie Feng, physician

Role: CONTACT

hunanxiefeng@yahoo.com.cn

+8613386272885

Facility Contacts

Xie Feng, attending physician

Role: primary

hunanxiefeng@yahoo.com.cn

+8613386272885

Other Identifiers

HCC-SL-2W

Identifier Type: -

Identifier Source: org_study_id