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

February 14, 2012 updated by: Xie feng, Second Military Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
        • Principal Investigator:
          • Xie Feng, attending physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other Names:
  • TS-1
  • formyltetrahydrofolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR
Time Frame: in two years
DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
in two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTP ( time to progression)
Time Frame: in 2 years
from enrolled to progression(iconography).
in 2 years
OS ( overall survival)
Time Frame: in two years
to death
in two years
safety
Time Frame: in two years
any adverse reaction by NCI-CTCAE 3.0
in two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Military Medical University

Investigators

  • Study Chair: Yang Jiamei, Chief, Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-SL-2W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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