Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma
Brief summary
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.
Interventions
PROCEDUREDEB-TACE
Drug-eluting beads transcatheter arterial chemoembolization
PROCEDUREcTACE
Transcatheter arterial chemoembolization
DEVICEDrug-eluting Beads
Drug-eluting beads
DRUGEpirubicin
Chemotherapy drug for intra-arterial infusion
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 70 years of age, of any sex; 2. Patients who have histopathological or cytological proof of hepatocellular carcinoma (HCC) or meet the diagnostic criteria of Diagnosis, management, and treatment of hepatocellular carcinoma(V2017); 3. Beyond UCSF criteria: Diameter of single HCC lesion is between 6.5 cm and 10 cm; The number of tumors ≤3 with the maximum diameter of 4.5-5cm and the total diameter ≤10cm; Multiple HCC lesions ≤5 nodules, each lesion diameter≤4 cm with a total diameter ≤10 cm. Patients cannot be treated with resection or liver transplantation; 4. Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ; 5. Child-Pugh's grade A or B (no more than 7 score); 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1; 7. Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy; 8. The function of main organs is normal and meet the following 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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Downstaging success rate | Within 6 months after surgery | Criteria for success rate in downstaging meet UCSF criteria or the standard for liver resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial response (PR) | 1, 3, 6 months after surgery | 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 |
| Stable disease (SD) | up to 6months after TACE procedure | 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 |
| Progressive disease (PD) | 1, 3, 6 months after surgery | 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 |
| Objective response (OR) | 1, 3, 6 months after surgery | CR+PR |
| Duration of downstaging | within 36 months | Interval between initial TACE treatment and the success or failure of downstaging according to the UCSF criteria assessed by the dynamic enhanced CT ; |
| Times of TACE treatments | within 36 months | Times of TACE surgery |
| Complete response (CR) | 1, 3, 6 months after surgery | Disappearance of any intratumoral arterial enhancement in all target lesions |
| Changes in liver function | from the date of the first TACE to the end of the clinical trial or the death of the patient，Up to 36months | 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) |
| Tumor-free survival (TFS) | Within 36 months | as the time from surgery initiation to tumor recurrence or death from any cause |
| Progression-free survival (PFS) | Within 36 months | as the time from surgery initiation to disease progression or death from any cause |
| Overall survival (OS) | Within 36 months | as the time from surgery initiation to death from any cause |
| Recurrence rate of Hepatocellular carcinoma | Within 36 months | Recurrence rate of hepatocellular carcinoma |
| Changes of tumor biomarkers (AFP, PIVKA-Ⅱ) | From 7 days before TACE or curative treatments to the endpoints of the trial.(Up to 36 months) | 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 |
Countries
China
Contacts
Primary ContactJiahong Dong, MD
Outcome results
None listed