Synergism of Immunomodulation and Tumor Ablation — ILOC  

Colorectal Cancer Clinical Trial

Official title: Phase II of Immunotherapy Plus Local Tumor Ablation (RFA or Stereotactic Radiotherapy) in Patients With Colorectal Cancer Liver Metastases

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

• NCT number: NCT03101475
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2018
• Completion date: February 23, 2022