Clinical trial NCT06779461: A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
Official title: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma Non-Resectable
Lead sponsor: InnoBM Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD
First posted: 2025-01-16
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: 30 days after the last TACE treatment.
Secondary outcomes:
measure: Success rate of embolization technique for the target lesion
timeFrame: on the day of the surgery
measure: DCR
timeFrame: 30 days after the first TACE treatment
measure: CR
timeFrame: 30 days after the first TACE treatment
measure: ORR
timeFrame: 90 days after the last TACE treatment
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Anyang
country: China
facility: Anyang Tumor Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Guangzhou
country: China
facility: The Third Affiliated Hospital,Sun Yat-Sen University
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
Study officials:
References: