Hepatocellular Carcinoma Non-Resectable
Conditions
Brief summary
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
Interventions
DEVICEMagnesium Microspheres
Biodegradable Magnesium Embolic Microspheres
PROCEDUREcTACE
cTACE
Sponsors
CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD
InnoBM Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18 to 80 years inclusive, regardless of gender; 2. 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; 3. ECOG score ≤ 2, and Child-Pugh classification of A or B; 4. 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); 5. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period; 6. Voluntary participation in this clinical trial and signing of the informed consent form by the subject.
Exclusion criteria
1. Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE; 2. Received other antitumor systemic treatment within 28 days before enrollment; 3. Unsuitable for TACE due to lesion characteristics or vascular issues; 4. Vp3/Vp4 portal vein tumor thrombus; 5. Tumor occupying ≥70% of liver volume; 6. Decompensated cirrhosis or recent ascites drainage/TIPS; 7. Severe allergies to contrast agents or embolization materials; 8. Received blood products or certain corrective treatments within 7 days before enrollment; 9. Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin); 10. Abnormal liver function tests (bilirubin, enzymes, albumin); 11. Renal impairment (creatinine, creatinine clearance); 12. Prolonged PT; 13. Unsuitable feeding artery for TACE or embolization risks; 14. Expected survival \<6 months; 15. Pregnant, lactating, or planning pregnancy; 16. Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases); 17. Severe infections unsuitable for TACE; 18. Participation in other clinical trials within 28 days before enrollment; 19. Other reasons deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 30 days after the last TACE treatment. | The objective response rate of the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of embolization technique for the target lesion | on the day of the surgery | Success rate of embolization technique for the target lesion |
| DCR | 30 days after the first TACE treatment | Disease control rate of the target lesion |
| CR | 30 days after the first TACE treatment | Complete Response of the target lesion |
| ORR | 90 days after the last TACE treatment | Objective Response Rate of the target lesion |
Countries
China
Contacts
Primary ContactChuntao G PM
Outcome results
None listed