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A Multicenter, Open Label, Single Arm, Phase II Study to Investigate the Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Patients With Advanced Hepatocellular Carcinoma (HCC)

Phase 2
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

A Multicenter, Open Label, Single Arm, Phase II Study to Investigate the Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Patients With Advanced Hepatocellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the fifth most common
cancer in the world. It is responsible for about 90 percent of the primary malignant liver
tumors observed in adult and disproportionately affects men, with about three times as many
men developing the disease as women.

Common symptoms in patients affected with HCC include abdominal pain, weight loss, weakness,
fullness and anorexia, abdominal swelling, jaundice and vomiting.

Multiple clinical staging systems for hepatic tumors have been used such as the American
Joint Committee on Cancer TNM system (stage 0, A, B, C, D) etc. However, the staging systems
are still evolving with all attempts to improve the classification and prognosis prediction
of HCC, and there is no agreement on the best staging that can be recommended world-wide.

For advanced HCC, sorafenib is likely to become the new standard of care. Combinational
therapies with sorafenib have the potential to further improved therapeutic options for
patients suffering from advanced HCC. Gemcitabine is a classical chemotherapeutic substance
that has modest anti-cancer activity in HCC. However, its anti-cancer activity seems to be
improved when combined with other anti-cancer drugs including drugs interfering with the
VEGF pathway. Both substances, sorafenib and gemcitabine, have a favorable safety profile
with a minimal overlap of side effects. Further the mode of actions of sorafenib and
gemcitabine are likely to result in synergistic anti-tumor effects.

An open label, single arm, multicenter phase II study designed to determine progression free
survival of patients with advanced stage HCC treated with sorafenib in combination with
gemcitabine. Patients will receive up to 6 cycles of gemcitabine(IV 1000 mg/m2 on day 1, 8,
15 of a 28-day cycle) in combination with sorafenib (400 mg po bid daily) followed by
sorafenib (400 mg po bid daily) maintenance until disease progression.

Inclusion Criteria:

- patient at least 18 years of age with written informed consent prior to enrollment
into the study.

- histologically or cytologically confirmed advanced unresectable and/or metastasis)

- Child-Pugh class A or B

- Have measurable disease according to RECIST criteria

- life expectancy of at least 12 weeks, ECOG 0-2

- Have adequate bone marrow reserve and liver and renal function at screening

- Practice adequate contraception during study participation

Exclusion Criteria:

- Exclude medical conditions including history of cardiac disease, HIV infection,active
infection,brain metastastasis or intracranial metastasis,seizure disorder requiring
medication, history of organ allograft,evidence of or history of bleeding
diathesis,previous or concurrent cancer with distinct in primary site or histology
(with exception of cervical carcinoma in situ and treated basal cell carcinoma

- Excluded therapies and medications, previous and concomitant : prior systemic
anticancer chemotherapy or immunotherapy or targeted therapy,hormonal therapy within
2 weeks,local treatment modality within 4 weeks,radiotherapy within 3 weeks,major
surgery and unhealed wound within 4 weeks,autologous bone marrow transplant or stem
cell rescue within 4 months

- other condition that may interfere with the patient's participation in the study or
evaluation of the results

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:

To evaluate the efficacy (progression free survival (PFS)) of sorafenib in patients with advanced/unresectable HCC.

Outcome Time Frame:

2.5 years

Safety Issue:


Principal Investigator

Vichien Srimuninnimit, Assist.Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Siriraj Hospital, Bangkok, Thailand


Thailand: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

August 2011

Related Keywords:

  • Carcinoma, Hepatocellular
  • Hepatocellular Carcinoma (HCC)
  • Carcinoma
  • Carcinoma, Hepatocellular