New drug combo shows promise for untreated liver cancer
NCT ID NCT04487067
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 3 trial tested a combination of two drugs, atezolizumab and bevacizumab, in 152 people with advanced liver cancer that could not be surgically removed and had not been treated before. The goal was to check safety and how well the treatment works. The study was open-label and single-arm, meaning everyone got the same treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atezolizumab (Tecentriq) and bevacizumab (Avastin)
- What this could lead to
- If successful, this combination could become a standard first-line treatment for advanced liver cancer, helping control the disease and extend survival.
- What could go wrong
- This is a single-arm study without a comparison group, so results may be less definitive. Side effects like bleeding are a known risk with these drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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152 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Aug 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Unresectable HCC with diagnosis confirmed by histology, with a biopsy within 6 months from recruitment; * Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies; * No prior systemic therapy for HCC; * At least one measurable untreated lesion; * Patients who received prior local therapy are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1; * ECOG Performance Status of 0 or 1 within 7 days prior to recruitment; * Child-Pugh class A within 7 days prior to recruitment; * Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed. In case of varices at high risk of bleeding (corresponding to medium (F2) or large (F3) varices, or F1 varices with cherry red spots or red wale marking) prophylatic treatment per local standard of care must be adopted prior to enrollment. Patients who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure provided they had no varices at high risk of bleeding; * Adequate hematologic and end-organ function * Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade \<= 1 prior to study entry, with the exception of alopecia * Negative HIV test at screening with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥200µL, and have an undetectable viral load; * In patients with viral HCC, documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test; * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm. Exclusion Criteria: * History of leptomeningeal disease or brain metastases; * Active or history of autoimmune disease or immune deficiency; * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; * Known active tuberculosis; * Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina; * History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death; * Prior allogeneic stem cell or solid organ transplantation; * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab and 6 months after the last dose of bevacizumab; * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding; * A prior bleeding event due to oesophageal and/or gastric varices within 6 months prior to initiation of study treatment; * Clinically evident ascites; * Co-infection of HBV and HCV; * Co-infection with HBV and hepatitis D viral infection; * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; * Clinically significant uncontrolled or symptomatic hypercalcemia; * Inadequately controlled arterial hypertension; * Significant vascular disease within 6 months prior to initiation of study treatment; * History of haemoptysis; * Evidence of bleeding diathesis or significant coagulopathy; * History of gastrointestinal (GI) fistula, GI perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment; * History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to initiation of study treatment; * Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume; * Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O. S. Orsola Malpighi
Bologna, Emilia-Romagna, 40138, Italy
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A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, 16132, Italy
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A.O.U Careggi
Florence, Tuscany, 50124, Italy
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A.O.U. Cagliari-P.O. Monserrato
Cagliari, Sardinia, 09100, Italy
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A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90127, Italy
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Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100, Italy
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Azienda Osp Uni Seconda Università Degli Studi Di Napoli
Naples, Campania, 80131, Italy
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Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Palermo, Sicily, 90127, Italy
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Azienda Ospedaliera Ordine Mauriziano di Torino
Turin, Piedmont, 10128, Italy
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Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00151, Italy
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Azlenda Ospendaliero-Universitaria Pisana
Pisa, Tuscany, 56100, Italy
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Clinica Oncologica-Ospedali Riuniti Ancona
Torrette, Tuscany, 60020, Italy
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Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
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Fondazione Pascale
Naples, Campania, 80100, Italy
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IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128, Italy
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IRCCS Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Apulia, 71013, Italy
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Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
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Istituto Nazionale Dei Tumori
Milan, Lombardy, 20133, Italy
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Ospedale del Mare
Naples, Campania, 80147, Italy
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Ospedali Riuniti - Bergamo
Bergamo, Lombardy, 24128, Italy
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Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
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