SIRT and Peri-immunotherapy : a New Concept
IMSIRT
Response Assessment for Advanced HCC of Combined SIRT and Immunotherapy Treatment
2 other identifiers
observational
60
1 country
1
Brief Summary
The combination of selective internal radiation therapy (SIRT) with immunotherapy represents an innovative and potentially highly effective therapeutic strategy for the treatment of advanced-stage hepatocellular carcinoma (BCLC stage B or C). Although promising results have been observed in preliminary clinical trials, further research is needed to better understand the underlying mechanisms, optimize treatment protocols, and confirm the long-term efficacy and safety of this combined approach
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
May 14, 2025
April 1, 2025
1.1 years
April 25, 2025
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Tumor Response Rate
Proportion of patients achieving complete or partial response, evaluated by CT or MRI using RECIST 1.1, mRECIST, iRECIST, and LI-RADS therapeutic criteria
At 3, 6, 9 and 12 months post-treatment
Secondary Outcomes (3)
Progression-Free Survival (PFS)
From treatment to disease progression or death, up to 12 months
Overall Survival (OS)
From treatment to death, up to 12 months
Treatment-Related Adverse Events
through study completion, an average of 1 year
Interventions
Atezolizumab ± Bevacizumab: Peri-immunotherapy with , with or without bevacizumab, given before and after SIRT. \- Yttrium-90 Radioembolization: Selective Internal Radiation Therapy (SIRT) via intra-arterial injection of Yttrium-90 microspheres for liver tumor control
Standard systemic immunotherapy administered without SIRT, using atezolizumab with or without bevacizumab.
Eligibility Criteria
Patients with advanced hepatocellular carcinoma (BCLC stage B or C), not eligible for curative treatments, treated with SIRT and/or immunotherapy
You may qualify if:
- Age ≥ 18 years Diagnosis of hepatocellular carcinoma (HCC) confirmed by imaging or biopsy Tumor \> 6 cm Child-Pugh score A to B7 Not eligible for curative treatment (resection, ablation, transplant, TACE) Macrovascular invasion or AFP \> 100 ng/mL Treated with intra-arterial Yttrium-90 SIRT combined with atezolizumab ± bevacizumab
You may not qualify if:
- Age \< 18 Non-HCC diagnosis on imaging or pathology Child-Pugh \> B7 Prior immunotherapy or intra-arterial hepatic treatment Under legal guardianship or curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Paul Brousse - Radiology Department
Villejuif, 94800, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maïté Lewin, Professor
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Paul Brousse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 14, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 14, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share