Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT04659382
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Checkpoint Inhibitor
  • Internal Radiotherapy
  • MSS
  • Metastatic Colorectal Cancer
  • pMMR

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab combined to standard chemotherapy (XELOX + bevacizumab) and targeted therapy in patients whose tumour has been made immunogenic by radiotherapy (Therasphere) and ICI (atezolizumab).
  • Therasphere — DEVICE
    Therasphere injected to patients to promote the release of neoantigens from their tumour and convert it into an immunogenic tumour.
  • XELOX — DRUG
    standard chemotherapy for first line treament of metastatic CRC (in pMMR and/or MSS patients)
  • Bevacizumab — DRUG
    standard targeted therapy associated with XELOX for first line treament of metastatic CRC (in pMMR and/or MSS patients)

Study Details

The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. SIRTCI is a single-arm, prospective, multi-centre phase II study. The main inclusion criteria are patients with MSS mRCC with predominantly non-operable liver metastases and measurable disease. Patients with extra-hepatic metastases can be included since the objective of the study is to induce local and abscopal effects of radiotherapy combined with ICI by stimulating the anti-tumour immune response to destroy both hepatic and extra-hepatic metastases.

Key Dates

Start date
Oct 7, 2020
Status verified
Aug 2023
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    XELOX + bevacizumab + atezolizumab + SIRT (Therasphere)

Primary Outcome Measure

Progression-free survival at 9 months [ Time Frame: 9 months after inclusion of the last patient ]

Central Contacts

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