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