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A Phase II Trial of Sorafenib Plus Tegafur-uracil (UFT) vs. Sorafenib as First Line Systemic Treatment for Patients With Advanced Stage HCC, Unresectable & Not Eligible for Local Ablation &/or TACE

Phase 2
18 Years
Open (Enrolling)
Advanced Hepatocellular Carcinoma

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Trial Information

A Phase II Trial of Sorafenib Plus Tegafur-uracil (UFT) vs. Sorafenib as First Line Systemic Treatment for Patients With Advanced Stage HCC, Unresectable & Not Eligible for Local Ablation &/or TACE

Inclusion Criteria:

- 1-The patient must provide written informed consent prior to enrollment into the

2-The patient must be at least 18 years of age. 3-Patients must have histologically
or cytologically confirmed or radiologically confirmed (according to AASLD criteria)
advanced (unresectable, and/or metastatic) HCC not eligible for local ablation or

4-Patients must have measurable disease according to RECIST criteria (at least one
uni-dimensional lesion measurable by CT-scan or MRI) 5-Patients must have a life
expectancy of at least 12 weeks 6-Patients must have an Eastern Co-operative Oncology
Group (ECOG) performance status of 0 -2, Child-Pugh class A and only B7 7-Adequate
bone marrow, liver and renal function as assessed by the following laboratory
requirements to be conducted within 7 days prior to screening:

- Hemoglobin ≥ 9.0 g/dl

- Absolute neutrophil count (ANC) ≥ 1,500/mm3

- Platelet count ≥ 100,000/μl

- Total bilirubin ≤ 1.5 times the upper limit of normal

- ALT and AST < 5 x upper limit of normal

- Alkaline phosphatase ≤ 5 x upper limit of normal

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

- Serum creatinine < 1.5 x upper limit

- Amylase and lipase < 1.5 X the upper limit of normal 8-For patients, who have
had major surgery or injury, the wound must be completely healed prior to
receiving sorafenib treatment (4 weeks).

9-Women of childbearing potential and men must agree to use adequate
contraception prior to study entry and for the duration of study participation.
Men use adequate birth control for at least 3 months after the last
administration of sorafenib

Exclusion Criteria:

Excluded medical conditions:

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

- History of HIV infection

- Patients with Child-Pugh class C hepatic impairment

- Patients with Child-Pugh class B (except 7 ) hepatic impairment

- Active clinically serious infections (grade 2 NCI-CTC version 3.0)

- Symptomatic metastatic brain or meningeal tumors

- Patients with seizure disorder requiring medication (such as steroids or

- History of organ allograft

- Patients with evidence or history of bleeding due to OV

- Patients undergoing renal dialysis

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma

Patients not fulfilling inclusion criteria.

Excluded therapies and medications, previous and concomitant:

- Prior systemic anticancer chemotherapy or immunotherapy or targeted therapy is not
allowed before study entry.

- Hormonal therapy shouldn't be given within 2 weeks before study entry and is not
allowed during the study.

- Patients who failed previous transcatheter arterial chemoembolism must have at least
4 weeks treatment free interval before entering the study

- Radiotherapy during study or within 3 weeks of start of study drug.

- Major surgery within 4 weeks of start of study

- Investigational drug therapy outside of this trial during or within 4 weeks of study

- 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 two weeks after the completion of trial.

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

- Known or suspected allergy to the investigational agent or any agent given in
association with this trial

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression (TTP):recist criteria

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Hamdy Abdelazim, MD/PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Cairo University


Egypt: Ministry of Health and Population

Study ID:

ESLC1 (SADAT study)



Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular