Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond University of California, San Francisco (UCSF) criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting bead transarterial chemoembolization(DEB-TACE) | Experimental |
| |
| conventional transarterial chemoembolization(cTACE) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB-TACE | Procedure | Drug-eluting beads transcatheter arterial chemoembolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Downstaging success rate | Criteria for success rate in downstaging meet UCSF criteria or the standard for liver resection. | Within 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR) | Disappearance of any intratumoral arterial enhancement in all target lesions | 1, 3, 6 months after surgery |
| Partial response (PR) | At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions |
Not provided
Inclusion Criteria:
1) Outcome of blood routine must meet the following criteria (No blood transfusion or blood products were performed within 4 days, and no g-CSF or other hematopoietic stimulants were used for correction): i. Hemoglobin(HB)≥90 g/L; ii. Absolute neutrophil count (ANC)≥1.5×109/L; iii. Platelet (PLT)≥80×109/L; 2) Outcome of hemal biochemistry examination meet the following criteria: i. Albumin (ALB) ≥29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5 × upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤2 × ULN; iv. Serum creatinine (SCr) ≤1.25 × ULN, or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula); 3) Patients who have normal livers with an Remnant Liver Volume (RLV)/Standard Liver Volume(SLV) >20% ; Patients who have cirrhosis with an RLV/SLV>40%; 9. Life expectancy of > 3 months; 10. Patients volunteered to participate in this study and signed informed consent, with good compliance.Exclusion Criteria.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiahong Dong, MD | Contact | 01056118763 | dongjiahong@mail.tsir |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Chang Gung Hospital | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cTACE | Procedure | Transcatheter arterial chemoembolization |
|
| Drug-eluting Beads | Device | Drug-eluting beads |
|
| Epirubicin | Drug | Chemotherapy drug for intra-arterial infusion |
|
| 1, 3, 6 months after surgery |
| Stable disease (SD) | Number of the subjects that do not qualify for partial response or progressive disease measured by modified Response Evaluation Criteria in Solid Tumors( mRECIST) criteria | up to 6months after TACE procedure |
| Progressive disease (PD) | An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started | 1, 3, 6 months after surgery |
| Objective response (OR) | CR+PR | 1, 3, 6 months after surgery |
| Duration of downstaging | Interval between initial TACE treatment and the success or failure of downstaging according to the UCSF criteria assessed by the dynamic enhanced CT ; | within 36 months |
| Times of TACE treatments | Times of TACE surgery | within 36 months |
| Changes of tumor biomarkers (AFP, PIVKA-Ⅱ) | AFP and PIVKA-II must be measured at 1week before, 1 week,1month after TACE or curative treatment; AFP ,PIVKA-II could be measured every 3-6 months during follow up according to the availability of equipment at the site | From 7 days before TACE or curative treatments to the endpoints of the trial.(Up to 36 months) |
| Changes in liver function | Changes of the Child-pugh Score that used to assess the prognosis of chronic liver disease,consisting of 5 items(ascites,total bilirubin,albumin,prothrombin time and degree of encephalopathy),of which is scored 1-3 points,with 3 indicating greatest severity) | from the date of the first TACE to the end of the clinical trial or the death of the patient,Up to 36months |
| Tumor-free survival (TFS) | as the time from surgery initiation to tumor recurrence or death from any cause | Within 36 months |
| Progression-free survival (PFS) | as the time from surgery initiation to disease progression or death from any cause | Within 36 months |
| Overall survival (OS) | as the time from surgery initiation to death from any cause | Within 36 months |
| Recurrence rate of Hepatocellular carcinoma | Recurrence rate of hepatocellular carcinoma | Within 36 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |