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PRISM: Preoperative Irradiation with STRIDE for HCC
NCT06994299Phase 2
Key facts
- Status
- Withdrawn
- Start
- Oct 2025
- Primary completion
- Jul 2027
- Countries
- 1
- Sponsor
- Weill Cornell Medicine
- Modality
- Antibody Conjugates, Engineered Antibody Formats, PD-1/PD-L1 Inhibitors
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of tremelimumab and durvalumab in hepatocellular carcinoma (HCC), sponsored by Weill Cornell Medicine. Primary endpoints: Grade 3+ CTCAE treatment related toxicity rates at 3 months and Major pathologic response rates at Week 7. Planned start Oct 2025; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Stereotactic Body Radiotherapy for HCC
Hypofractionated radiotherapy + Tremelimumab + Durvalumab followed by Surgery
03
Who it enrols
Adult patients with resectable hepatocellular carcinoma (LIRADS 5 or biopsy confirmed), ECOG 0-1, and adequate organ function. Excludes patients with prior anti-PD-1/CTLA-4 therapy, autoimmune disease, HIV, or active tuberculosis.
04
Endpoints
Primary
Grade 3+ CTCAE treatment related toxicity rates
Major pathologic response rates
Secondary
Recruitment timeline
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