Prospective, multicenter, randomized controlled trial to validate the safety and efficacy of polyvinyl alcohol embolization microspheres for transarterial chemoembolization of liver cancer
- Conditions
- Primary hepatic carcinoma
- Registration Number
- ChiCTR2400088959
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
(1) 18 years old = age =80 years old, gender is not limited;<br>(2) Patients with liver cancer from stage lb to stage Illa who require transarterial chemoembolization (TACE) and are not suitable for/refuse surgical resection, liver cancer transplantation or ablation;<br>(3) Liver function grade Child-Pugh A or B;<br>(4) ECOG score of the patient's physical status =2 points;<br>(5) The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion =10cm);<br>(6) Those who agree to participate in the clinical trial and voluntarily sign the informed consent.
(1) Patients with target lesions who have previously received embolization therapy or who need combined ablative radiotherapy after the first TACE treatment of target lesions in the human group;<br>(2) Patients with extensive distant metastasis and expected survival <3 months;<br>(3) dysfluid or multiple organ failure;<br>(4) Patients with severe liver dysfunction (liver function Child-Pugh grade C) and renal dysfunction (blood creatinine > 2mg/dL);<br>(5) Significant reduction of white blood cells and platelets in patients with white blood cells <3.0x 10^9/L and platelets < 50x 10^9/L (except patients with hyperplenism and chemotherapy myelosuppression)<br>(6) uncorrectable coagulation dysfunction;<br>(7) Patients with active hepatitis or severe infection who cannot be treated with TACE at the same time;<br>(8) The main portal vein was completely embolized by cancer embolus;<br>(9) The target lesion blood supply artery can not be TACE treatment or there is a risk of embolization (vascular access endangers normal areas, arteriovenous fistula, portal venous fistula, etc.);<br>(10) Patients with uncontrolled diabetes or a history of bilioenteric surgery within the past 1 year;<br>(11) Known severe hypersensitivity to contrast media or embolic materials;<br>(12) Pregnant/lactating women, or those who plan to give birth;<br>(13) Patients who have participated in clinical trials of other drugs or devices within 3 months;<br>(14) Other patients deemed unsuitable for the clinical trial by the investigator;
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate of target lesions 1 month after the last TACE;
- Secondary Outcome Measures
Name Time Method Embolization success rate of target lesion;Disease control rate of target lesions 1 month after the first TACE and 3 months after the last TACE;Objective response rate of target lesion 1 month after the first TACE and 1 month and 3 months after the last TACE;Times of TACE treatments for target lesions;Mortality during the study period;Device performance evaluation;