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NCT05776875

Atezolizumab and Bevacizumab in Combination With TACE for Patients With BCLC B HCC

Terminated Phase 2 Results posted Last updated 15 January 2025
What this trial tests

Phase 2 trial testing Atezolizumab Injection in Hepatocellular Carcinoma in 3 participants. Terminated before completion.

Timeline
7 June 2023
Primary endpoint
5 December 2024
5 December 2024

Quick facts

Lead sponsorYale University
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date7 June 2023
Primary completion5 December 2024
Estimated completion5 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with Hepatocellular Carcinoma or BCLC Stage B Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Grade 3 or Higher Treatment Related Adverse Events Primary · up to 18 months

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.

GroupValue95% CI
Atezolizumab and Bevacizumab in Combination With TACE1
Response Rate in Solid Tumors Secondary · up to 18 months

Response 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.

GroupValue95% CI
Atezolizumab and Bevacizumab in Combination With TACE0
Atezolizumab and Bevacizumab in Combination With TACE0
Atezolizumab and Bevacizumab in Combination With TACE3
Atezolizumab and Bevacizumab in Combination With TACE0
Response Rate in Hepatocellular Carcinoma Secondary · up to 18 months

Response 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 n

GroupValue95% CI
Atezolizumab and Bevacizumab in Combination With TACE0
Atezolizumab and Bevacizumab in Combination With TACE0
Atezolizumab and Bevacizumab in Combination With TACE3
Atezolizumab and Bevacizumab in Combination With TACE0

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Atezolizumab and Bevacizumab in Combination With TACE
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (27 terms — click to expand)

ReactionSystemAtezolizumab and Bevacizum…
Aspartate aminotransferase increasedInvestigations
AnorexiaMetabolism and nutrition disorders
FatigueGeneral disorders
Alanine aminotransferase increasedInvestigations
HypoalbuminemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
HeadacheNervous system disorders
BloatingGastrointestinal disorders
ConstipationGastrointestinal disorders
NauseaGastrointestinal disorders
Edema limbsGeneral disorders
Flu like symptomsGeneral disorders
PainGeneral disorders
Blood bilirubin increasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
Lymphocyte count decreasedInvestigations
Weight gainInvestigations
Weight lossInvestigations
White blood cell decreasedInvestigations
HyperglycemiaMetabolism and nutrition disorders
Memory impairmentNervous system disorders
Abdominal distensionGastrointestinal disorders
DiarrheaGastrointestinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
AnemiaBlood and lymphatic system disorders
BruisingInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT05776875 adverse events section.

Sponsor's own description

There is an unmet need for patients with intermediate stage hepatocellular carcinoma (HCC). It is known that local tumor ablation can increase tumor immunogenicity by releasing tumor associated antigens, potentially increasing the response to immune therapy not just locally, but systemically. In addition, there is now positive data with immune therapy in advanced HCC, there is renewed interest in the combination of local therapy and systemic therapy in Barcelona Clinic Liver Clinic B (BCLC B) patients with systemic therapies other than sorafenib. Based on this data, the investigators plan to examine the atezolizumab and bevacizumab combination with Transarterial Chemoembolization (TACE) in patients with BCLC B HCC.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
    Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282
  2. Current Perspectives on Perioperative Combination Therapy for Hepatocellular Carcinoma.
    Nishio T, Yoh T, Nishino H, Ogiso S, et al · · 2025 · cited 5× · PMID 40528897 · DOI 10.1159/000546138
  3. Insights in Molecular Therapies for Hepatocellular Carcinoma.
    Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831
  4. The role of immunotherapy prior to liver transplantation in advanced or down-staged HCC - timing of transplants, selection of patients, and hurdles to overcome with immunosuppression.
    Tabrizian P, Chan A, Marino R, Giudicelli H, et al · · 2026 · PMID 41186530 · DOI 10.1097/js9.0000000000003520
  5. Interventional oncology and immunotherapy: current status and future perspectives.
    Ma J, Wei Z, Ye X. · · 2025 · PMID 40264767 · DOI 10.3389/fimmu.2025.1541105

Verify or expand the search:

Other trials of Atezolizumab Injection

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

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