TACE-HAIC+Atezolizumab+Bevacizumab for Unresectable HCC: a Phase 2 Clinical Trial
Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05751343
Collaborator
(none)
55
1
1
24.2
2.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
55 participants
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 2400 mg/m2 of continuous 5-FU infusion for 46 hours or 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeksThe 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 2400 mg/m2 of continuous 5-FU infusion for 46 hours or 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeks
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transarterial Chemoembolization Plus Hepatic Artery Infusion Chemotherapy and Atezolizumab Plus Bevacizumab for Unresectable Hepatocellular Carcinoma: a Single-arm Phase 2 Clinical Trial
Anticipated Study Start Date
:
Feb 23, 2023
Anticipated Primary Completion Date
:
Feb 28, 2024
Anticipated Study Completion Date
:
Feb 28, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TACE-HAIC plus atezolizumab-bevacizumab transartery chemoembolization and hepatic artery infusion of FOLFOX followed by intravenous of 1200mg atezolizumab plus bevacizumab (15mg/kg) |
Drug: TACE-HACI, plus atezolizumab-bevacizumab
transartery chemoembolization and artery infusion of FOLFOX, followed by intravenous atezolizumab plus bevacizumab
|
Outcome Measures
Primary Outcome Measures
- Objective response rate [12 months]
objective response rate based on mRECIST
Secondary Outcome Measures
- progress-free survival [12 months]
Progress-free survival (PFS) was defined from the date of treatment to the first image-confirmed progress or died.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yunfei Yuan,
Professor,
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05751343
Other Study ID Numbers:
- 2022-FXY-141
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: