Hepatocellular Carcinoma
Conditions
Brief summary
Atezolizumab and bevacizumab was approve for advanced unresectable hepatocellular carcinoma (aHCC). Whether the additional of transartial chemobolization and hepatic artery infusion chemotherapy will improve the response rate for those patients is still unknown. This phase 2 clinical trial aims to investigate the objective response rate for unresectable advanced hepatocellular carcinoma.
Interventions
DRUGTACE-HACI, plus atezolizumab-bevacizumab
transartery chemoembolization and artery infusion of FOLFOX, simultaneously followed by intravenous atezolizumab plus bevacizumab
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The TACE-HAIC which was performed using 30 mg/m2 of epirubicin mixed with 2-5 mL lipiodol, followed by pure lipiodol. Then, a catheter was placed and fixed in the tumor feeding artery for the FOLFOX-based chemotherapy infusion at the following dosage: 85 mg/m2 of oxaliplatin infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; 400 mg/m2 of 5-FU bolus; and 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* (a) patients were diagnozied with unresectable advanced-stage HCC, * (b) Child-Pugh A or B liver function; * (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; * (e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L);
Exclusion criteria
* (a) severe underlying cardiac, pulmonary, or renal diseases; * (b) history of a second primary malignant tumor; * (c) contraindication to either atezolizumab and bevacizumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 12 months | objective response rate based on RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate based mRECIST | 12 months | objective response rate based on modified RECIST criteria |
| progress-free survival | 12 months | Progress-free survival (PFS) was defined from the date of treatment to the first image-confirmed progress based on RECIST 1.1, last follow-up or died. |
| overall survival | 12 months | Overall survival was defined from the date of treatment to the date of died or last follow-up |
| adverse event | 12 months | adverse event was assessed according to the NCI-CTCAEV 5.0 |
Countries
China
Outcome results
None listed