TACE-HAIC Plus Atezolizumab and Bevacizumab for Unresectable HCC: a Phase 2 Clinical Trial
Phase 2
Recruiting
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: TACE-HACI, plus atezolizumab-bevacizumab
- Registration Number
- NCT05751343
- Lead Sponsor
- Sun Yat-sen University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TACE-HAIC plus atezolizumab-bevacizumab TACE-HACI, plus atezolizumab-bevacizumab transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by intravenous of 1200mg atezolizumab plus bevacizumab (15mg/kg)
- Primary Outcome Measures
Name Time Method Objective response rate 12 months objective response rate based on mRECIST
- Secondary Outcome Measures
Name Time Method progress-free survival 12 months Progress-free survival (PFS) was defined from the date of treatment to the first image-confirmed progress or died.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center🇨🇳Guangzhou, Guangdong, China