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Phase 1 Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma

Phase 1
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Phase 1 Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma

Inclusion Criteria:

1. Patients with histologically confirmed hepatocellular carcinoma (HCC) or a
combination of radiologically compatible finding to HCC, alpha-fetoprotein>400ng/mL
and liver cirrhosis

2. Inoperable disease as defined by

1. Localized disease in a portion of the liver that doses not allow the possibility
of complete surgical removal of the tumor with a clear resection margin OR

2. Presence of extra-hepatic disease OR

3. Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR

4. The HCC must not be amenable to intra-arterial therapy or local ablative therapy

3. Minimum life expectancy of 12 weeks

4. Age>18 years.

5. ECOG Performance Status of 0-1

6. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening:

1. Hemoglobin>9.0 g/dl

2. Absolute neutrophil count (ANC) >1,500/mm3

3. Platelet count > 75,000/μl

4. Total bilirubin < 1.5 times the upper limit of normal

5. ALT and AST <5 x upper limit of normal

6. Albumin >= 3g/dL

7. PT-INR/PTT <1.5 x upper limit of normal

8. Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance

7. Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

1. Decompensated cirrhosis or stage C according to the Child-Pugh Classification

2. Chemo-embolization within 8 weeks of inclusion

3. Other concomitant anticancer agent, including Tamoxifen and Interferon

4. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI
more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring
anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled

5. History of HIV infection

6. Active clinically serious infections (> grade 2 CTCAE version 3.0)

7. Symptomatic metastatic brain or meningeal tumors

8. Patients with seizure disorder requiring medication (such as steroids or

9. History of organ allograft

10. Patients with evidence or history of bleeding diathesis

11. Patients undergoing renal dialysis

12. Radiotherapy during study or within 4 weeks of start of study drug.

13. Major surgery within 4 weeks of start of study

14. Autologous bone marrow transplant or stem cell rescue within 4 months of study

15. Prior exposure to the study drug.

16. Pregnant or breast-feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within 7 days of the start of treatment. Both men
and women enrolled in this trial must use adequate barrier birth control measures
during the course of the trial (and men for at least 3 months after last
administration of study medication).

17. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

18. Any condition that is unstable or could jeopardize the safety of the patient and
their compliance in the study

19. Patients unable to swallow oral medications.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Primary objectives: 1. To determine maximal tolerated dose (MTD) of S-1 combined with fixed dose of sorafenib 400mg twice daily. Secondary objectives: 1. To evaluate toxicity profiles and dose-limiting toxicity (DLT)

Outcome Time Frame:

1 year

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

September 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • metastatic HCC
  • Carcinoma
  • Carcinoma, Hepatocellular