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 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
Hubert Blum, Prof. Dr. med. Dr. h. c.
University Hospital Freiburg
Germany: Federal Institute for Drugs and Medical Devices
AMT/P2GI/001 Part I