Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003

A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma

The primary endpoint is best overall response rate within 20 weeks after registration

The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.

The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

Inclusion Criteria:

• Cancer confirmed by histology or cytology
• At least one measurable lesion
• Advanced disease refractory to standard therapy or for which no standard therapy exists
• Life expectancy of at least 3 months

Exclusion Criteria:

• Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
• Body weight below 45 kg
• Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
• Confirmed diagnosis of HIV
• Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
• Chemotherapy or radiotherapy less than 4 weeks prior to entry
• Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
• Participation in a clinical trial less than 30 days prior to entry into study