MedTrace Logo

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

NCT04659382 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-08-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Atezolizumab

Atezolizumab combined to standard chemotherapy (XELOX + bevacizumab) and targeted therapy in patients whose tumour has been made immunogenic by radiotherapy (Therasphere) and ICI (atezolizumab).

DEVICE

Therasphere

Therasphere injected to patients to promote the release of neoantigens from their tumour and convert it into an immunogenic tumour.

DRUG

XELOX

standard chemotherapy for first line treament of metastatic CRC (in pMMR and/or MSS patients)

DRUG

Bevacizumab

standard targeted therapy associated with XELOX for first line treament of metastatic CRC (in pMMR and/or MSS patients)

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659382 on ClinicalTrials.gov