A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC

Sponsor
GrandPharma (China) Co., Ltd.
Study ID
NCT07334483
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Yttrium [90Y] Microsphere Injection — DRUG
    Yttrium \[90Y\] microsphere injection should be implanted through the hepatic artery based on 99mTc-MAA SPECT/CT simulated surgery (Mapping) to evaluate the distribution of microsphere in the body, and calculate the activity required for treatment
  • Conventional transcatheter arterial chemoembolization — OTHER
    For the operation method of cTACE, please refer to the Clinical Practice Guidelines for Transcatheter Arterial Chemoembolization (TACE) Treatment of Hepatocellular Carcinoma in China (2023 Edition) and its related standard operating procedures (SOPs).
  • Camrelizumab — DRUG
    The first dose of Cycle 1 should be completed within 3 days after randomization. After Cycle 1 Day 1 (C1D1), it should be dosed every 3 weeks ± 3 days. Dosing may be delayed due to holidays, but should not exceed 7 days
  • Apatinib — DRUG
    Apatinib will be used from Cycle 2 Day 1 (C2D1). Apatinib should be discontinued for at least 7 days before and after treatment with yttrium \[90Y\] microsphere injection

Study Details

This study is A Randomized, Active-Controlled, Open-Label National Multicenter Phase 2 Registration Clinical Study of Yttrium \[90Y\] Microsphere Injection in Combination with Camrelizumab and/or Apatinib and Yttrium \[90Y\] Microsphere Injection Alone versus Conventional Transcatheter Arterial Chemoembolization (cTACE) in the Treatment of Unresectable or Non-Ablative, Non-Metastatic Hepatocellular Carcinoma (HCC). Its aim is to evaluate the efficacy and safety of yttrium \[90Y\] resin microsphere injection combined with Camrelizumab and/or apatinib compared with yttrium \[90Y\] resin microsphere injection alone in the treatment of inoperable or ablatable, non-metastatic HCC.

Key Dates

Start date
Aug 22, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Yttrium \[90Y\] microsphere injection selective internal radiation therapy (SIRT) + camrelizumab + apatinib
  • Experimental: Group B
    Yttrium \[90Y\] microsphere injection SIRT + camrelizumab
  • Experimental: Group C
    Yttrium \[90Y\] microsphere injection SIRT
  • Active Comparator: Group D
    Conventional transcatheter arterial chemoembolization

Primary Outcome Measure

ORR [ Time Frame: up to 18 months ]

Central Contacts

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