Spots Global Cancer Trial Database for Synergism of Immunomodulation and Tumor Ablation

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Trial Identification

Brief Title: Synergism of Immunomodulation and Tumor Ablation

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

Study ID: NCT03101475

Conditions

Colorectal Cancer

Liver Metastases

Interventions

Durvalumab (MEDI4736)

Tremelimumab

Sterotactic body radiation therapy (SBRT)

Radiofrequency ablation (RFA)

Study Description

Brief 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

Detailed Description: