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

NCT01533324 | Unknown Phase 2 DMC

• 1 other identifier: HCC-SL-2W
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma; Liver Diseases; Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; S-1; Leucovorin; fluorouracil

Outcome Measures

Primary Outcomes (1)

• DCR

  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 Outcomes (3)

• TTP ( time to progression)

  in 2 years

• OS ( overall survival)

  in two years

• safety

  in two years

Study Arms (1)

S-1 combined with LV

EXPERIMENTAL

S-1 combined with LV

Drug: S-1 combined with Leucovorin

Interventions

S-1 combined with Leucovorin DRUG

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

Also known as: TS-1, formyltetrahydrofolate

S-1 combined with LV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Military Medical University: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Liver Diseases; Carcinoma, Hepatocellular

Interventions

Leucovorin; titanium silicide; Formyltetrahydrofolates

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Diseases; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Yang Jiamei, Chief

  Second Military Medical University

  STUDY CHAIR

Central Study Contacts

Xie Feng, physician

CONTACT

+8613386272885; hunanxiefeng@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

CN (1)