Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, TACE, Microspheres
Brief summary
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Detailed description
This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.
Interventions
DEVICEDEB-TACE with visualable microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
DEVICEDEB-TACE with PVA microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
DEB-TACE with visualable microspheres or PVA microspheres
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B * ECOG PS score of 0-2 * With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm) * Agree to participate in this trial and voluntarily sign the informed consent form
Exclusion criteria
* Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s) * With diffuse liver tumor or extrahepatic metastasis, expected survival \<6 months With sepsis or multiple organ dysfunction * Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine \>2 mg/dL) * Significant reductions in white blood cells or platelets (white blood cells \<3.0×10\^9/L, platelets \<50×10\^9/L, hemoglobin\<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by \>3 seconds above the upper limit of normal) * With severe infection (\>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply * With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries * Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection * Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs * Pregnant or lactating women * Patients who are participating in other trial(s) * Unsuitable for participation in this trial deemed by the researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) for target lesions 1 month after the last TACE treatment | 1 month after last TACE treatment | Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Embolization success rate of target lesions | Immediately after each TACE treatment | Defined as the number of successful embolizations for the target lesions / the total number of participants ×100%. |
| Equipment performance evaluation | From the begin to immediately after each TACE treatment | Includes,the visualization performance of the microspheres on the fluoroscopy or cone-beam CT imaging; whether the microspheres can be easy pushed and pass through the catheter smoothly; whether the micro-catheter will be blocked during the process of pushing and releasing? |
| Visualization score of embolic area | Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment | Evaluation will be performed, based on CBCT images after the first TACE treatment, or CT plain images after the last TACE treatment as follow: 3 points: dense imaging (imaging area \>75% of tumor area); 2 points: mixed imaging (imaging area 25%-75% of tumor area); 1 point: weak imaging (imaging area \<25% of tumor area); 0 point: not visible (no imaging in the tumor area). |
| Objective response rate（ORR） | 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment | Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images. |
| Number of TACE treatments for target lesions | 6 month since the last TACE treatment | Totel times of TACE treatments for all target lesions |
| Disease control rate (DCR) for target lesions | 1 month after the first TACE treatment, and 3 months after the last TACE treatment | Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images. |
Countries
China
Contacts
Primary ContactHai-Dong Zhu
Outcome results
None listed