To hear about similar clinical trials, please enter your email below
Trial Title:
TACE-HAIC Plus Atezolizumab and Bevacizumab for Unresectable HCC: a Phase 2 Clinical Trial
NCT ID:
NCT05751343
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TACE-HACI, plus atezolizumab-bevacizumab
Description:
transartery chemoembolization and artery infusion of FOLFOX, simultaneously followed by
intravenous atezolizumab plus bevacizumab
Arm group label:
TACE-HAIC plus atezolizumab-bevacizumab
Summary:
Transartial chemobolization plus hepatic artery infusion chemotherapy showed performance
for unresectable hepatocellular carcinoma (HCC). Whether the additional of atezolizumab
plus bevacizumab 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
hepatocellular carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (a) patients were diagnozied with unresectable 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiliang Qiu
Phone:
+862087342651
Email:
qiujl@sysucc.org.cn
Start date:
March 9, 2023
Completion date:
February 28, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751343
