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Starting soon Observational

SIRT and Peri-immunotherapy : a New Concept

NCT06971237 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-06-01
Last updated
2025-05-14

Condition(s) studied

Advanced Hepatocellular Carcinoma (HCC), Classified as BCLC Stage B or C, Treated With a Combination of Selective Internal Radiation Therapy

Investigational drug(s) / intervention(s)

Atezolizumab ± Bevacizumab and Yttrium-90 RadioembolizationAtezolizumab ± Bevacizumab →

Atezolizumab ± Bevacizumab and Yttrium-90 Radioembolization: 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

Atezolizumab ± Bevacizumab: Standard systemic immunotherapy administered without SIRT, using atezolizumab with or without bevacizumab.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: Age \< 18 Non-HCC diagnosis on imaging or pathology Child-Pugh \> B7 Prior immunotherapy or intra-arterial hepatic treatment Under legal guardianship or curatorship

Primary outcome measure(s)

  • Objective Tumor Response Rate — At 3, 6, 9 and 12 months post-treatment
    Proportion of patients achieving complete or partial response, evaluated by CT or MRI using RECIST 1.1, mRECIST, iRECIST, and LI-RADS therapeutic criteria

Trial sites (1)

FacilityCityRegionStatus
Hôpital Paul Brousse - Radiology Department Villejuif France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06971237 on ClinicalTrials.gov ↗ ← All trials in France