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.
Patients who voluntarily participate in this study, sign the informed consent form (ICF), and are able to comply with the diagnosis, treatment, observation, follow-up visit and related procedures specified in this protocol, with good compliance.
Patients aged ≥ 18 and ≤ 75, regardless of gender.
HCC confirmed by pathological histology/cytology, or meeting the clinical diagnostic criteria in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) established by the National Health Commission.
Patients who are not suitable for surgery (including hepatectomy and liver transplantation) or ablation treatment based on the judgment of investigator or clinical practice guidelines, or refuse surgery or ablation treatment.
Cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma confirmed by pathological histology or cytology.
Invasive HCC, that is, imaging shows that microscopic or small tumor nodules are diffusely distributed in a certain liver lobe or the entire liver.
Based on liver volume, the tumor burden is relatively large (>50%).
Presence of hepatic vein or inferior vena cava tumor thrombus, or involvement of the superior mesenteric vein or more distant end.
Parallel
Yttrium [90Y] Microsphere Injection
DrugYttrium \[90Y\] 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 interventionFor 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
DrugThe 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
DrugApatinib 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
ORR
Objective Response Rate, assessed by blinded independent central review (BICR) based on mRECIST criteria
PFS
Progression-free survival (PFS, assessed by BICR based on mRECIST and RECIST v1.1 criteria)
ORR
Objective Response Rate (assessed by BICR based on RECIST v1.1 criteria)
hPFS
Hepatic Progression-free survival (hPFS) (assessed by BICR and investigator based on mRECIST criteria)
hORR
Hepatic Objective Response Rate (hORR) (assessed by BICR and investigator based on mRECIST criteria)
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