About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Yttrium [90Y] Microsphere Injection
- Conventional transcatheter arterial chemoembolization
- Camrelizumab
- Apatinib