S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Second Military Medical University.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Xie feng, Second Military Medical University
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
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.
Drug: S-1 combined with Leucovorin
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2016 (Final data collection date for primary outcome measure)
Experimental: S-1 combined with LV
S-1 combined with LV
Drug: 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
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).
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01533324
|Eastern Hepatobiliary Surgery Hospital
|Shanghai, Shanghai, China, 200438 |
Second Military Medical University
||Yang Jiamei, Chief
||Second Military Medical University
||Xie feng, attending physician, Second Military Medical University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2012
||February 14, 2012
||China: Food and Drug Administration
Keywords provided by Second Military Medical University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Vitamin B Complex
Physiological Effects of Drugs