A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy
TerminatedPhase 3Results postedLast updated 8 May 2025
What this trial tests
Phase 3 trial testing Atezolizumab in Carcinoma, Hepatocellular in 100 participants. Terminated before completion.
18 and older, any sex, with Carcinoma, Hepatocellular. 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.
Number of Participants Who Discontinued Atezolizumab and/or Bevacizumab Due to Adverse Events (AE) of Grade ≥ 3Primary· From Cycle 1 Day 1 up to 30 days after the final dose of the study drug or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 32 months)
AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of AEs was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) with the following grades: Grade 1 = asymptomatic or mild symptom
Group
Value
95% CI
Atezolizumab + Bevacizumab
19
Overall Survival (OS)Secondary· Up to 35 months
OS was defined as the time from initiation of study treatment to death from any cause. OS was analyzed using Kaplan-Meier (K-M) methods and Greenwood's formula. Any participant who did not die during the study was censored at the last known date to be alive.
Group
Value
95% CI
Atezolizumab + Bevacizumab
24.8
18.55 – NA
Progression-free Survival (PFS)Secondary· Up to 35 months
PFS was defined as the time from initiation of study treatment to the first occurrence of disease progression (PD) or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). PFS was analyzed using K
Group
Value
95% CI
Atezolizumab + Bevacizumab
9.3
7.01 – 12.40
Objective Response Rate (ORR)Secondary· Up to 35 months
ORR = percentage of participants with a complete or partial response (CR or PR), on 2 consecutive investigator assessments ≥ 4 weeks apart in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1. CR = disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to \< 10 mm. PR = at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants without a post-baseline tumor assessment were considered non-responders. 95% confidence in
Group
Value
95% CI
Atezolizumab + Bevacizumab
24.2
16.9 – 33.5
Time to Progression (TTP)Secondary· Up to 35 months
TTP was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, SOD must also demonstrate an absolute increase of ≥ 5 mm. TTP was analyzed using K-M methods and Greenwood's formula. Any participant who had no disease progression was censored at the last known date without disease progression.
Group
Value
95% CI
Atezolizumab + Bevacizumab
11.2
8.30 – 13.59
Duration of Response (DOR)Secondary· Up to 35 months
DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at
Group
Value
95% CI
Atezolizumab + Bevacizumab
15.9
7.87 – 23.74
Percentage of Participants Who Started Second-line TreatmentSecondary· Up to 35 months
Participants who started second-line of treatment were assessed. Percentages have been rounded off.
Group
Value
95% CI
Atezolizumab + Bevacizumab
24.2
Change From Baseline in International Normalized Ratio (INR)Secondary· Baseline up to Cycle 42 (1 cycle = 21 days)
The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants to evaluate coagulation parameters.
Baseline
Group
Value
95% CI
Atezolizumab + Bevacizumab
1.1
± 0.1
Cycle 42
Group
Value
95% CI
Atezolizumab + Bevacizumab
0.1
± 0.0
Change From Baseline in Albumin-Bilirubin (ALBI) ScoreSecondary· Baseline up to Cycle 42 (1 cycle = 21 days)
Blood samples were collected from participants to evaluate of ALBI grades. ALBI assessment grades of 1 to 3 was based on ALBI score calculation. ALBI score= log10 bilirubin (micromole per liter) \[μmol/L\] × 0.66 + albumin (grams per liter) \[g/L\] × -0.0852. ALBI score ≤ -2.60 = ALBI grade 1; -2.60 \< ALBI score ≤ -1.39 = ALBI grade 2 and -1.39 \< ALBI score = ALBI grade 3.
Baseline
Group
Value
95% CI
Atezolizumab + Bevacizumab
-2.7
± 0.4
Cycle 42
Group
Value
95% CI
Atezolizumab + Bevacizumab
0.4
± 0.4
Percentage of Participants With Ascites and/or Hepatic EncephalopathySecondary· Up to approximately 32 months
Deterioration of hepatic function was monitored by presence of ascites and/or hepatic encephalopathy.
Group
Value
95% CI
Atezolizumab + Bevacizumab
17
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs and SAEs: From Cycle 1 Day 1 up to 30 days after the final dose of the study drug or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 32 months). All cause mortality: Up to 35 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Atezolizumab + Bevacizumab:
Serious: 46/100 (46%)
Deaths: 51/100
Serious adverse events (64 terms)
Reaction
System
Atezolizumab + Bevacizumab:
Hepatic Encephalopathy
Nervous system disorders
—
Oesophageal Varices Haemorrhage
Gastrointestinal disorders
—
Ascites
Gastrointestinal disorders
—
Back Pain
Musculoskeletal and connective tissue disorders
—
Hepatitis
Hepatobiliary disorders
—
Pyrexia
General disorders
—
Abdominal Pain
Gastrointestinal disorders
—
Gastrointestinal Haemorrhage
Gastrointestinal disorders
—
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
—
Pneumonia
Infections and infestations
—
Pneumonia Pneumococcal
Infections and infestations
—
Urinary Tract Infection
Infections and infestations
—
Spinal Cord Compression
Nervous system disorders
—
General Physical Health Deterioration
General disorders
—
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
—
Hip Fracture
Injury, poisoning and procedural complications
—
Blood Bilirubin Increased
Investigations
—
Diarrhoea
Gastrointestinal disorders
—
Hepatic Function Abnormal
Hepatobiliary disorders
—
Immune-Mediated Hypothyroidism
Endocrine disorders
—
Tumour Associated Fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a Phase IIIb, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic HCC not previously treated with systemic therapy. As part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
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NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
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NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec
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NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 8 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04732286.