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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Second Military Medical University
Sponsor:
Information provided by (Responsible Party):
Xie feng, Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01533324
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012

February 10, 2012
February 14, 2012
November 2011
November 2016   (final data collection date for primary outcome measure)
DCR [ Time Frame: in two years ] [ Designated as safety issue: No ]
DCR means patient got the best reaction and last for more than 4 weeks DCR=(CR)+ (PR)+ (SD) by RESIST 1.1
Same as current
Complete list of historical versions of study NCT01533324 on ClinicalTrials.gov Archive Site
  • TTP ( time to progression) [ Time Frame: in 2 years ] [ Designated as safety issue: No ]
    from enrolled to progression(iconography).
  • OS ( overall survival) [ Time Frame: in two years ] [ Designated as safety issue: No ]
    to death
  • safety [ Time Frame: in two years ] [ Designated as safety issue: Yes ]
    any adverse reaction by NCI-CTCAE 3.0
Same as current
Not Provided
Not Provided
 
S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)
Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma

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.

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).

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma
  • Liver Diseases
  • Hepatocellular Carcinoma
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
Other Names:
  • TS-1
  • formyltetrahydrofolate
Experimental: S-1 combined with LV
S-1 combined with LV
Intervention: Drug: S-1 combined with Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
December 2016
November 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Xie Feng, physician +8613386272885 hunanxiefeng@yahoo.com.cn
China
 
NCT01533324
HCC-SL-2W
Yes
Xie feng, Second Military Medical University
Second Military Medical University
Not Provided
Study Chair: Yang Jiamei, Chief The Second Military Medical University
Second Military Medical University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP