Trial Outcomes & Findings for Organ-specific Responses to Atezolizumab Plus Bevacizumab in Advanced HCC (NCT NCT04862949)
NCT ID: NCT04862949
Last Updated: 2025-12-12
Results Overview
Organ-specific response will be assessed at the lesion level according to RECIST 1.1 criteria. Up to two target lesions per organ (maximum of five total lesions per patient) will be selected and measured unidimensionally. Complete response (CR) is defined as disappearance of the lesion or lymph node short axis diameter \<1.0 cm. Partial response (PR) is defined as ≥30% reduction in lesion size. Progressive disease (PD) is defined as ≥20% increase in lesion size. Stable disease (SD) is defined as neither CR, PR, nor PD. New lesions are recorded in addition to original target lesions to determine the total tumor burden.
COMPLETED
131 participants
From treatment initiation until last follow-up (median 10.1 months)
2025-12-12
Participant Flow
Participant milestones
| Measure |
Atezolizumab Plus Bevacizumab
Atezolizumab plus bevacizumab
Atezolizumab plus bevacizumab: Atezolizumab plus bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Organ-specific Responses to Atezolizumab Plus Bevacizumab in Advanced HCC
Baseline characteristics by cohort
| Measure |
Atezolizumab Plus Bevacizumab
n=131 Participants
Atezolizumab plus bevacizumab
Atezolizumab plus bevacizumab: Atezolizumab plus bevacizumab
|
|---|---|
|
Age, Continuous
Age
|
62 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
131 Participants
n=26 Participants
|
|
Region of Enrollment
South Korea
|
124 participants
n=26 Participants
|
|
Region of Enrollment
Hong Kong
|
7 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until last follow-up (median 10.1 months)Population: Organ-specific responses were assessed for 260 individual tumor lesions from 131 participants who received atezolizumab plus bevacizumab: 152 liver lesions, 42 lymph node lesions, 24 lung lesions, and 42 other metastatic lesions were evaluated.
Organ-specific response will be assessed at the lesion level according to RECIST 1.1 criteria. Up to two target lesions per organ (maximum of five total lesions per patient) will be selected and measured unidimensionally. Complete response (CR) is defined as disappearance of the lesion or lymph node short axis diameter \<1.0 cm. Partial response (PR) is defined as ≥30% reduction in lesion size. Progressive disease (PD) is defined as ≥20% increase in lesion size. Stable disease (SD) is defined as neither CR, PR, nor PD. New lesions are recorded in addition to original target lesions to determine the total tumor burden.
Outcome measures
| Measure |
Atezolizumab Plus Bevacizumab
n=260 lesion
Atezolizumab plus bevacizumab
Atezolizumab plus bevacizumab: Atezolizumab plus bevacizumab
|
|---|---|
|
Percentage of Lesions With Organ-specific Response
ORR for 260 individual tumor lesions
|
29.8 Percentage of Units (lesions)
|
|
Percentage of Lesions With Organ-specific Response
ORR for 152 liver lesions
|
28.3 Percentage of Units (lesions)
|
|
Percentage of Lesions With Organ-specific Response
ORR for 42 LNs lesions
|
40.5 Percentage of Units (lesions)
|
|
Percentage of Lesions With Organ-specific Response
ORR for 24 lungs lesions
|
29.1 Percentage of Units (lesions)
|
|
Percentage of Lesions With Organ-specific Response
ORR for other metastatic lesions
|
19.0 Percentage of Units (lesions)
|
Adverse Events
Atezolizumab Plus Bevacizumab
Serious adverse events
| Measure |
Atezolizumab Plus Bevacizumab
n=131 participants at risk
Atezolizumab plus bevacizumab
Atezolizumab plus bevacizumab: Atezolizumab plus bevacizumab
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleeding (Grade ≥3)
|
4.6%
6/131 • Number of events 6 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Renal and urinary disorders
Proteinuria (Grade ≥3)
|
2.3%
3/131 • Number of events 3 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Vascular disorders
Hypertension (Grade ≥3)
|
2.3%
3/131 • Number of events 3 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
General disorders
Other treatment-related SAEs
|
3.1%
4/131 • Number of events 4 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
Other adverse events
| Measure |
Atezolizumab Plus Bevacizumab
n=131 participants at risk
Atezolizumab plus bevacizumab
Atezolizumab plus bevacizumab: Atezolizumab plus bevacizumab
|
|---|---|
|
Renal and urinary disorders
Proteinuria
|
11.5%
15/131 • Number of events 15 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
General disorders
Fatigue
|
19.8%
26/131 • Number of events 26 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.3%
20/131 • Number of events 20 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
16/131 • Number of events 16 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.9%
13/131 • Number of events 13 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
12/131 • Number of events 12 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
|
Vascular disorders
Hypertension
|
13.7%
18/131 • Number of events 18 • From treatment initiation until last follow-up (median 10.1 months)
Adverse events were collected from the start of treatment until last follow-up, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place