Trial Outcomes & Findings for LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC (NCT NCT05537402)
NCT ID: NCT05537402
Last Updated: 2026-06-18
Results Overview
Evaluate the efficacy of atezolizumab and bevacizumab compared to TACE or TARE as measured by progression-free survival after randomization. PFS is defined as time from randomization to death from any cause or radiologic tumor progression, according to investigator assessment per mRECIST (modified Response Evaluation Criteria in Solid Tumors ).
TERMINATED
PHASE2
1 participants
Baseline until date of first observed disease progression or death, assessed up to 24 months
2026-06-18
Participant Flow
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Participant milestones
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Arm A: Atezolizumab and Bevacizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Atezolizumab will be administered first followed by bevacizumab, with a minimum of 5 minutes between dosing.
Atezolizumab and bevacizumab: Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle and Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle
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Arm B: Locoregional Therapy With TACE or TARE
Patients will undergo locoregional therapy with TACE or TARE per investigator preference.
TACE will be administered every 8 +/- 4 weeks; TARE will be administered every 12 +/- 4 weeks. Proportion of patients being treated with TARE will be capped at 50% of cohort at a protocol level. After 50% cap is reached, patients randomized to Arm B will be treated with TACE.
transarterial chemoembolization (TACE) or transarterial radioembolization (TARE: TACE cycles occur every 8 weeks +/- 7 days OR TARE cycles occur every 12 weeks +/- 7 days
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Overall Study
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline until date of first observed disease progression or death, assessed up to 24 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Evaluate the efficacy of atezolizumab and bevacizumab compared to TACE or TARE as measured by progression-free survival after randomization. PFS is defined as time from randomization to death from any cause or radiologic tumor progression, according to investigator assessment per mRECIST (modified Response Evaluation Criteria in Solid Tumors ).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until date of first observed disease progression or death, assessed up to 24 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
To evaluate the efficacy of atezolizumab and bevacizumab compared to locoregional therapy with TACE or TARE as measured by ORR. ORR to be assessed using investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until date of first observed disease progression or death, assessed up to 24 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
To evaluate the efficacy of atezolizumab and bevacizumab compared to locoregional therapy with TACE or Time to treatment failure, defined as time to death or inability to provide allocated treatment (atezolizumab/bevacizumab for Arm A or TACE/TARE for Arm B). Failure of strategy can be based on loss of clinical benefit, unacceptability toxicity, liver function deterioration, or no longer applicable as determined by local tumor board.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until date of death, assessed up to 24 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
To evaluate the efficacy of atezolizumab and bevacizumab compared to locoregional therapy with TACE or TARE as measured by OS. Overall survival after randomization, defined as time from randomization to death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization until first clinically meaningful deterioration in liver function, assessed up to 24 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Time to deterioration of liver function, defined as time from randomization to first clinically meaningful deterioration in liver function, as measured by Child Pugh and ALBI. Meaningful increases in Child Pugh will be defined as increase in Child Pugh score to 8 and meaningful increased changes in ALBI will be defined as an increase in ALBI grade (from grade 1 to 2 or grade 2 to 3).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to first clinically meaningful deterioration of quality of life, assessed up to 24 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
To evaluate health related quality of life scores of patients treated with atezolizumab and bevacizumab compared to locoregional therapy with TACE or TARE. Time to deterioration of quality of life, defined as time for randomization to first clinically meaningful deterioration of quality of life measured by EORTC QLQ-C30 and EORTC-QLQ-HCC18.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Atezolizumab and Bevacizumab
Arm B: Locoregional Therapy With TACE or TARE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Hsieh
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place