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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
University Hospital Freiburg, Dept. of Internal Medicine II
Freiburg im Breisgau, Baaden-Wuerttemberg, Germany
Clinic SanaFontis
Freiburg im Breisgau, Germany
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
Time frame: March 2010
Progression Free Survival (PFS) time
Time frame: March 2010
Overall Survival (OS) time
Time frame: March 2010
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Time frame: March 2010
Safety and Tolerability
Time frame: March 2010
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