Efficacy and Safety of Yttrium-90 Microspheres Selective Internal Radiotherapy Combined with Immune Checkpoint Inhibitors and Anti-angiogenesis Drugs Sequential HAIC for Hepatocellular Carcinoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06867432
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + Bevacizumab — DRUG
    Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by 1200mg atezolizumab + 15mg/kg bevacizumab administered by IV at every 3 weeks for 18 months. HAIC：administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.

Study Details

To observe and evaluate the efficacy and safety of selective internal radiotherapy (SIRT) based on transarterial radioembolization with yttrium (90Y) microspheres combined with immune checkpoint inhibitors and anti-angiogenic-drug sequential hepatic arterial infusion chemotherapy (HAIC) for the treatment of initially unresectable hepatocellular carcinoma with transformation potential.

Key Dates

Start date
Mar 1, 2025
Status verified
Feb 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2027

Study Design

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

Arms

  • Experimental: SIRT-Y90+HAIC+PD-1 or PD-L1 inhibitors +targeted therapy
    Yttrium (90Y) -SIRT treatment: SIRT enables resin-based yttrium (90Y) microspheres. The radioactivity of yttrium (90Y) and the therapeutic dose were calculated by the body surface product method. The designated dose of yttrium (90Y) microsphere injection was infused after hepatic arterial catheterization, tumor donor artery. The treatment sessions targeted the liver lobe with a larger tumor volume. Patients were monitored for 2 days after treatment. In cases of local tumor progression and contraindications, SIRT may be repeated. Hepatic arterial infusion chemotherapy: specific drug dose, drug method according to current guidelines and drug marketing instructions. Every 3 weeks starting after 3 weeks of yttrium (90Y) -SIRT. PD-L1/PD-1 inhibitors and targeted therapy as specified in the guidelines are allowed to be administered during each treatment

Primary Outcome Measure

ORR mRESIST [ Time Frame: Prior to surgery ]

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