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A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Phase 3 trial testing Atezolizumab in Carcinoma, Hepatocellular in 668 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 668 |
| Start date | 31 December 2019 |
| Primary completion | 21 October 2022 |
| Estimated completion | 15 May 2026 |
| Sites | 134 locations across Hong Kong, Italy, Japan, Taiwan, Poland, South Korea, New Zealand, Costa Rica |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).
| Group | Value | 95% CI |
|---|---|---|
| Arm B (Active Surveillance) | NA | 21.4 – NA |
| Arm A (Atezolizumab Plus Bevacizumab) | NA | 22.1 – NA |
Serum concentration of atezolizumab.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | NA | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 440 | ± 132 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 88.7 | ± 30.4 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 137 | ± 53.0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 159 | ± 58.5 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 196 | ± 86.2 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 202 | ± 90.1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 204 | ± 89.2 |
Number of participants with anti-drug antibodies to atezolizumab.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Atezolizumab Plus Bevacizumab) | 75 |
Time frame: From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Active Surveillance | Atezolizumab+Bevacizumab | Crossover: Atezolizumab+Be… |
|---|---|---|---|---|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Bile duct stone | Hepatobiliary disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Cataract | Eye disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Varices oesophageal | Gastrointestinal disorders | — | — | — |
| Acute hepatic failure | Hepatobiliary disorders | — | — | — |
| Immune-mediated hepatitis | Hepatobiliary disorders | — | — | — |
| Pneumonia aspiration | Infections and infestations | — | — | — |
| Rib fracture | Injury, poisoning and procedural complications | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | — | — | — |
| Arteriosclerosis coronary artery | Cardiac disorders | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Deafness neurosensory | Ear and labyrinth disorders | — | — | — |
| Reaction | System | Active Surveillance | Atezolizumab+Bevacizumab | Crossover: Atezolizumab+Be… |
|---|---|---|---|---|
| Proteinuria | Renal and urinary disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Fatigue | General disorders | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hyperthyroidism | Endocrine disorders | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — |
| Weight increased | Investigations | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
Most-reported serious reactions: Oesophageal varices haemorrhage, COVID-19, Ascites, Pyrexia, Bile duct stone, Platelet count decreased, Pneumonitis, Hypertension.
Data from ClinicalTrials.gov NCT04102098 adverse events section.
This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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