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

Primary Purpose

Carcinoma, Liver Diseases, Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1 combined with Leucovorin
Sponsored by
Second Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring hepatocellular carcinoma, S-1, Leucovorin, fluorouracil

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Eastern Hepatobiliary Surgery HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 combined with LV

Arm Description

S-1 combined with LV

Outcomes

Primary Outcome Measures

DCR
DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1

Secondary Outcome Measures

TTP ( time to progression)
from enrolled to progression(iconography).
OS ( overall survival)
to death
safety
any adverse reaction by NCI-CTCAE 3.0

Full Information

First Posted
February 10, 2012
Last Updated
February 14, 2012
Sponsor
Second Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01533324
Brief Title
S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)
Official Title
Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Liver Diseases, Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, S-1, Leucovorin, fluorouracil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-1 combined with LV
Arm Type
Experimental
Arm Description
S-1 combined with LV
Intervention Type
Drug
Intervention Name(s)
S-1 combined with Leucovorin
Other Intervention Name(s)
TS-1, formyltetrahydrofolate
Intervention Description
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
Primary Outcome Measure Information:
Title
DCR
Description
DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
Time Frame
in two years
Secondary Outcome Measure Information:
Title
TTP ( time to progression)
Description
from enrolled to progression(iconography).
Time Frame
in 2 years
Title
OS ( overall survival)
Description
to death
Time Frame
in two years
Title
safety
Description
any adverse reaction by NCI-CTCAE 3.0
Time Frame
in two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xie Feng, physician
Phone
+8613386272885
Email
hunanxiefeng@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Jiamei, Chief
Organizational Affiliation
Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xie Feng, attending physician
Phone
+8613386272885
Email
hunanxiefeng@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xie Feng, attending physician

12. IPD Sharing Statement

Learn more about this trial

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

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