Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.

Phase 2

• Conditions: Hepatocellular carcinoma

• Registration Number: JPRN-UMIN000007199
• Lead Sponsor: Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-01
• Study Completion: 2013-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1)Previous therapy for hepatocellular carcinoma within 30days before study entry 2)Major surgery within 30 days before study entry or surgery within 15 days before study entry 3)Portal vein tumor thrombus in the main trunk 4)Uncontrollable hypertension 5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics 6)get an albumin preparation or a blood transfusion within 30 days before study entry 7)Hepatoencepharopathy. Brain lesions with clinical symptoms 8)Central nerve system tumor(including brain metastasis) 9)Bone metastasis with clinical symptoms 10)Active infection(except HBV and HCV infection) 11)Evidence of serious gastrointestinal bleeding within 30days before study entry 12)Gastro-esophageal varices requiring preventive treatment 13)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment 14)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence) 15)Severe hypersensitivity of TS-1 or sorafenib 16)Severe complication 17)Any patients judged by the investigator to be unfit to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to progression

Secondary Outcome Measures

Name	Time	Method
Overall survival Response rate Disease control rate Incidence of adversed effect