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New drug combo shows promise for untreated liver cancer

NCT ID NCT04487067

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

152 people

The number who actually took part.

Started

Aug 2020

Finished

Aug 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • A.O. S. Orsola Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • A.O. Universitaria S. Martino Di Genova

    Genoa, Liguria, 16132, Italy

  • A.O.U Careggi

    Florence, Tuscany, 50124, Italy

  • A.O.U. Cagliari-P.O. Monserrato

    Cagliari, Sardinia, 09100, Italy

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90127, Italy

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100, Italy

  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

    Palermo, Sicily, 90127, Italy

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Turin, Piedmont, 10128, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00151, Italy

  • Azlenda Ospendaliero-Universitaria Pisana

    Pisa, Tuscany, 56100, Italy

  • Clinica Oncologica-Ospedali Riuniti Ancona

    Torrette, Tuscany, 60020, Italy

  • Fondazione IRCCS Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Fondazione Pascale

    Naples, Campania, 80100, Italy

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • IRCCS Ospedale Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, Apulia, 71013, Italy

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

  • Istituto Nazionale Dei Tumori

    Milan, Lombardy, 20133, Italy

  • Ospedale del Mare

    Naples, Campania, 80147, Italy

  • Ospedali Riuniti - Bergamo

    Bergamo, Lombardy, 24128, Italy

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

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