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Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

Phase 1/Phase 2
20 Years
74 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for
the treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor
tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2
(VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor
receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid
tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is
also expected to be effective against HCC. However, because most HCC patients have
accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of
liver function impairment.

Inclusion Criteria:

- Age 20-74

- PS 0-2

- Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy

- Chid-Pugh A or B

- At least one measurable lesion by RECIST criteria

Exclusion Criteria:

- Large amount of pleural effusion or ascites

- Esophageal varices

- Simultaneously active double cancer

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:

Step 1(Phase I) Safety

Outcome Time Frame:

During chemotherapy

Safety Issue:


Principal Investigator

Masao Omata, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Yamanashi Prefectural Central Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2003

Completion Date:

March 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular