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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Military Medical University
• Treatments: Formyltetrahydrofolates; Leucovorin

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.