The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres.
The main questions it aims to answer are:
* Is the treatment more effective than traditional TACE alone? * What additional medical issues arise when using the microspheres?
Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.
Participants will:
* Receive up to 3 treatments of TACE with or without microspheres * Undergo checkups and tests every 30 days * Keep records of tumor size and other safety issues
Age range: 18 to 80 years inclusive, regardless of gender;
Patients with primary hepatocellular carcinoma (HCC) at CNLC stage Ib to IIIa who require transarterial chemoembolization (TACE) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy;
ECOG score ≤ 2, and Child-Pugh classification of A or B;
Presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mRECIST criteria (the maximum diameter of the target lesion ≤ 10.0 cm);
Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;
Received other antitumor systemic treatment within 28 days before enrollment;
Unsuitable for TACE due to lesion characteristics or vascular issues;
Vp3/Vp4 portal vein tumor thrombus;
InnoBM Pharmaceuticals Co., Ltd.
Lead sponsor
CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD
Collaborator