Clinical trial NCT05770635: Polyvinyl Alcohol Embolization Microspheres
Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Polyvinyl Alcohol Embolization Microspheres for Transarterial Chemoembolization of Primary Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Liver Cancer
Lead sponsor: Shanghai Huihe Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of polyvinyl alcohol embolization microspheres developed and manufactured by Shanghai Huihe Medical Technology Co., LTD. (hereinafter referred to as Huihe Medical) for transarterial chemoembolization of primary liver cancer using a prospective, multi-center, randomized controlled method


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years old; age ≤85 years old; regardless of gender
2. Patients with CNLC Ib, IIa, IIb, IIIa who need transarterial chemoembolization (TACE) therapy and are not suitable for or refuse surgical resection, liver transplantation, and ablation, and patients with stage IIIb primary liver cancer who are expected to benefit from TACE therapy to control the growth of intrahepatic tumors;
3. Child-Pugh A or B (less than 10 points);
4. performance status (PS) score of ECOG 0\~2;
5. The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion ≤10cm);
6. Those who agree to participate in the clinical trial and voluntarily sign the informed consent;

Exclusion Criteria:

1. Patients whose target lesions had received embolization therapy, whose target lesions had received other local treatments besides TACE (including but not limited to surgery, radiotherapy, hepatic arterial perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within 1 month, or who had received first TACE therapy for target lesions combined with ablation/radiotherapy after inclusion;
2. The proportion of tumor in total liver volume was ≥70%;
3. Patients with distant extensive metastasis or other malignant tumors;
4. The expected survival time is less than 3 months;
5. Cachexia or multiple organ failure;
6. Severe liver dysfunction (Child-Pugh grade C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome;
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal or \>250U/L, and ≥2 times the upper limit of normal after 1 week of liver protection and antiviral treatment;
8. Renal dysfunction: patients with serum creatinine \> 2mg/dL;
9. Blood leukocytes and platelets decreased significantly, leukocytes \< 3.0×109/L, platelets \< 50×109/L (except patients with hyperplenism and chemotherapy myelosuppression);
10. Bleeding and thrombotic tendency: patients with known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophiliacs, uncorrectable coagulation disorders, thrombocytopenia, hyperplenism, etc.), active peptic ulcer or gastrointestinal bleeding within 30 days; Arteriovenous thrombosis occurred in the past 6 months (until enrollment);
11. Patients with active hepatitis or severe infection who cannot be treated with TACE simultaneously;
12. Patients with complete obstruction of the main portal vein and unable to restore portal blood flow through compensatory collateral branches of the portal vein;
13. The target focal blood supply arteries cannot be treated with TACE or have the risk of embolization (vascular access endangers normal areas, arteriovenous fistula, portal fistula, etc.);
14. Subjects who predicted that the target lesion would require more than three TAces; Uncontrolled diabetes mellitus; 15.

16. People with known severe allergy to contrast agents, iodine contrast agents or embolic materials; 17. Pregnant/lactating women, or those who plan to give birth; 18. Patients who are participating in clinical trials of other drugs or devices and have not been in the group or have been in the group for less than 1 month; 19. Persons without the ability to make independent decisions or with mental illness; 20. Other patients deemed unsuitable for this clinical trial by the investigator;

Primary outcomes:
measure: Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation
timeFrame: 1 month after the last TACE -mRECIST evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Huihe Healthcare Tecnology Co.,Ltd.
state: Shanghai
Study officials:
References: