A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma

Phase 3

Not yet recruiting

• Conditions: Hepatocellular Carcinoma Non-Resectable

• Registration Number: NCT06779461
• Lead Sponsor: InnoBM Pharmaceuticals Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-25
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ORR	30 days after the last TACE treatment.	The objective response rate of the target lesion

Secondary Outcome Measures

Name	Time	Method
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
ORR	90 days after the last TACE treatment	Objective Response Rate of the target lesion
CR	30 days after the first TACE treatment	Complete Response of the target lesion

Trial Locations

Locations (10)

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, Anhui, China

Anyang Tumor Hospital; 🇨🇳 Anyang, Henan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China

Lishui Central Hospital; 🇨🇳 Lishui, Zhejiang, China

The Third Affiliated Hospital,Sun Yat-Sen University; 🇨🇳 Guangzhou, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, China

The First Affiliated Hospital of Henan University of Science & Technology; 🇨🇳 Luoyang, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, China