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Trial Title:
Polyvinyl Alcohol Embolization Microspheres
NCT ID:
NCT05770635
Condition:
Primary Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Embosphere and chemotherapy drug
Description:
chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's
condition
Arm group label:
Embosphere and chemotherapy drug
Intervention type:
Device
Intervention name:
Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
Description:
chemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is
selected according to the subject's condition
Arm group label:
Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
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
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Address:
City:
Shanghai
Zip:
201615
Country:
China
Start date:
December 28, 2022
Completion date:
December 28, 2024
Lead sponsor:
Agency:
Shanghai Huihe Medical Technology Co., Ltd
Agency class:
Industry
Source:
Shanghai Huihe Medical Technology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05770635
