This is a single-arm, open-label, multi-center early phase II study. This proof of concept
study will investigate whether the combined use of local tumor ablation/radiation plus
immunomodulating drugs may induce a significant immune response in patient with incurable
liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable
or in partial remission after completion of 4-6 months first line systemic therapy.
The primary objective of the study is to show an overall response rate of lesions not treated
by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria)
higher than 10%. With the continuation of first line systemic treatment, no further responses
are expected.
Secondary objectives are:
- To establish the feasibility and safety of the combined treatment modalities;
- To study the impact of the local technique (RFA/Radiotherapy) on the results;
- To investigate biomarkers to predict response to the combined treatment
Phase:
Phase 2
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC