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

Second Military Medical University

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Carcinoma

Liver Diseases

Treatments

Drug: S-1 combined with Leucovorin

Study type

Interventional

Funder types

Other

Identifiers

NCT01533324

HCC-SL-2W

Details and patient eligibility

About

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.

Full 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).

Enrollment

32 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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
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.