Trial Outcomes & Findings for Atezolizumab and Bevacizumab in Combination With TACE for Patients With BCLC B HCC (NCT NCT05776875)
NCT ID: NCT05776875
Last Updated: 2025-01-15
Results Overview
Safety and tolerability will be assessed by the rate of grade 3 or higher Adverse Events (AEs), graded using the CTCAE version 5. The rate will be assessed using the Bayesian Predictive Probability approach. Due to early termination of the study, reported here is the number of participants that experienced any grade 3 or higher event.
TERMINATED
PHASE2
3 participants
up to 18 months
2025-01-15
Participant Flow
Participant milestones
| Measure |
Atezolizumab and Bevacizumab in Combination With TACE
THIS IS A SINGLE ARM PILOT/FEASIBILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT.
The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule.
Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.
For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Transarterial chemoembolization: Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.
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|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atezolizumab and Bevacizumab in Combination With TACE for Patients With BCLC B HCC
Baseline characteristics by cohort
| Measure |
Atezolizumab and Bevacizumab in Combination With TACE
n=3 Participants
THIS IS A SINGLE ARM PILOT/FEASIBILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT.
The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule.
Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.
For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Transarterial chemoembolization: Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 18 monthsSafety and tolerability will be assessed by the rate of grade 3 or higher Adverse Events (AEs), graded using the CTCAE version 5. The rate will be assessed using the Bayesian Predictive Probability approach. Due to early termination of the study, reported here is the number of participants that experienced any grade 3 or higher event.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab in Combination With TACE
n=3 Participants
THIS IS A SINGLE ARM PILOT/FEASIBILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT.
The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule.
Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.
For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Transarterial chemoembolization: Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.
|
|---|---|
|
Grade 3 or Higher Treatment Related Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 18 monthsResponse Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) will be used to assess overall response rate. Complete Response (CR): disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Due to early termination of the study, a formal overall response rate could not be calculated. Presented here is the overall response frequency by RECIST 1.1 criteria type.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab in Combination With TACE
n=3 Participants
THIS IS A SINGLE ARM PILOT/FEASIBILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT.
The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule.
Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.
For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Transarterial chemoembolization: Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.
|
|---|---|
|
Response Rate in Solid Tumors
Partial response (PR)
|
0 Participants
|
|
Response Rate in Solid Tumors
Stable disease (SD)
|
0 Participants
|
|
Response Rate in Solid Tumors
Complete Response (CR)
|
3 Participants
|
|
Response Rate in Solid Tumors
Progressive Disease (PD)
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 18 monthsResponse Evaluation Criteria in Hepatocellular Carcinoma-Specific Modified RECIST (HCC mRECIST) will be used to assess overall response rate. Complete response (CR): When all visible tumor areas on the arterial phase disappear, indicating complete necrosis. Partial response (PR): A significant decrease (≥ 30%) in the size of the enhancing tumor areas on the arterial phase. Stable disease (SD): No significant change in tumor size, neither shrinkage nor progression. Progressive disease (PD): An increase in the size of the enhancing tumor areas on the arterial phase (≥ 20%) or the appearance of new enhancing lesions.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab in Combination With TACE
n=3 Participants
THIS IS A SINGLE ARM PILOT/FEASIBILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT.
The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule.
Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.
For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Transarterial chemoembolization: Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.
|
|---|---|
|
Response Rate in Hepatocellular Carcinoma
Partial Response (PR)
|
0 Participants
|
|
Response Rate in Hepatocellular Carcinoma
Stable Disease (SD)
|
0 Participants
|
|
Response Rate in Hepatocellular Carcinoma
Progressive disease (PD)
|
0 Participants
|
|
Response Rate in Hepatocellular Carcinoma
Complete Response (CR)
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Data not collected.
Defined as the time from trial enrollment until objective tumor progression by RECIST, Response Evaluation Criteria in Solid Tumors criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Data not collected.
Defined as the interval of time from the day of the images after a TACE procedure to the time or progression, new vascular invasion or extrahepatic spread also is counted as progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Data not collected.
Defined as time to untreatable tumor progression and/or transient deterioration to Child-Pugh C score and/or appearance of vascular invasion/extrahepatic spread. Child-Pugh score ranges from 5-15. Child-Pugh C = 10-15. A higher score indicates a worse outcome.
Outcome measures
Outcome data not reported
Adverse Events
Atezolizumab and Bevacizumab in Combination With TACE
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atezolizumab and Bevacizumab in Combination With TACE
n=3 participants at risk
THIS IS A SINGLE ARM PILOT/FEASABILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT.
The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule.
Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.
For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Transarterial chemoembolization: Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.
|
|---|---|
|
General disorders
Fatigue
|
66.7%
2/3 • 18 months
|
|
General disorders
Edema limbs
|
33.3%
1/3 • 18 months
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • 18 months
|
|
General disorders
Pain
|
33.3%
1/3 • 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • 18 months
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • 18 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • 18 months
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • 18 months
|
|
Investigations
Weight gain
|
33.3%
1/3 • 18 months
|
|
Investigations
Weight loss
|
33.3%
1/3 • 18 months
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
3/3 • 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • 18 months
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • 18 months
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • 18 months
|
|
Gastrointestinal disorders
Bloating
|
66.7%
2/3 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 18 months
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 18 months
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place