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New hope for liver cancer: triple therapy shows promise

NCT ID NCT05665348

Disease control Sponsor: Federation Francophone de Cancerologie Digestive Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a third drug, ipilimumab, to the standard two-drug combination (atezolizumab and bevacizumab) improves survival and tumor shrinkage in people with advanced liver cancer. About 229 patients will receive either the standard two drugs or all three. The goal is to see if the triple therapy works better for those who cannot have surgery or other local treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ipilimumab (added to atezolizumab and bevacizumab)
What this could lead to
If successful, this could offer a more effective first-line treatment option for advanced liver cancer, potentially extending survival.
What could go wrong
This is a phase II-III trial, so results are not yet conclusive. Adding ipilimumab may increase side effects without improving outcomes.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

229 people

The number who actually took part.

Started

Mar 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age ≥ 18 years * Histologically proven hepatocellular carcinoma (HCC) on biopsy less than two years old. If no histological evidence, a tumour (mandatory) and non-tumour (optional) liver biopsy is required. * WHO 0 or 1 * HCC not amenable to curative treatment by surgery, thermo-ablation or liver transplantation, or to intra-arterial palliative treatment (IAP) for intermediate BCLC-B HCC. Advanced (BCLC-C) or intermediate (BCLC-B) HCC after failure or contraindication of the CEL * Normal Troponin-T * Patients with controlled cardiovascular disease for at least 6 months * No clinically evident ascites, no history of clinical ascites, or encephalopathy due to liver failure * Adequate liver function: AST and ALT ≤ 5 x ULN (upper normal limit), total bilirubin ≤ 35 µM/L, albumin ≥ 28 g/L and Child-Pugh A score (if associated cirrhosis) * Hematological (hemoglobin \> 8.5 g/dL, platelets \> 60 G/L, PNN \> 1.5 G/L) and renal function (creatinine clearance ≥ 40ml/min according to the appropriate MDRD formula) * At least one target lesion measurable according to RECIST v1.1 criteria * Oesophageal endoscopy less than 6 months old. All patients with varicose veins of any grade should be treated with β-blockers prior to initiation of therapy, in the absence of contraindications. * Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sex with women of childbearing potential must agree to use contraception during treatment and for at least 6 months after discontinuation of the experimental treatments * Ability of the patient to understand, sign and date the informed consent form before randomisation * Patient affiliated to a social security scheme Exclusion Criteria: * Patients who have already received systemic therapy for HCC * Bleeding related to portal hypertension in the last 6 months * History of abdominal or oesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, diverticulitis or colitis within 6 months prior to randomisation * Patients on double anti-platelet aggregation therapy * Patients on chronic non-steroidal anti-inflammatory drugs (except aspirin). * History of intra-abdominal inflammatory process within 6 months prior to initiation of treatment - including but not limited to - active peptic ulcer, diverticulitis or colitis * Major surgery or significant traumatic injury within 28 days prior to treatment, abdominal surgery or significant abdominal traumatic injury within 60 days prior to treatment, or the need for major surgery during the therapeutic trial * Hypersensitivity to any of the study drugs or their excipients * Allergy to one of the components of Chinese hamster ovary cells. * Other malignant tumours within the last 2 years, except for carcinoma in situ of the uterus or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered curedHistory of severe active life-threatening autoimmune disease * Interstitial lung disease * Chronic HBV infection with HBV DNA \> 500 IU/ml, infected patients, cirrhotic or not, should be treated with nucleotide/nucleoside analogues. * Known HIV infection * Immunosuppression, including subjects with conditions requiring systemic corticosteroid treatment (\>10 mg/day prednisone equivalent) * History of organ transplantation * Non-healing decaying wound, active ulcer or untreated bone fracture * Proteinuria ≥ 2+ on urine dipstick if confirmation of 24h proteinuria showing a level ≥ 2 g/24 hours * Medically uncontrolled hypertension (≥ 150 mm Hg and/or diastolic blood pressure superior to 90 mm Hg) * History of arterial aneurysm at high risk of bleeding * Alive attenuated vaccine within 28 days prior to randomisation * History of pericardial abnormalities possibly immune-related (pericarditis or cardiac tamponade) * Patient who has received immunotherapy (including anti-CTLA-4, anti-PD-1 or anti-PD-L1 agents) or anti-VEGF antibody therapy * Patients who has previously received external radiotherapy up to 1 month before the start of the study treatment, or 3 months before the start of the study treatment in case of radio embolization * Central nervous system metastases * Active bacterial infection * Patients with uncontrolled cardiovascular disease * History of arterial thromboembolic events, including stroke, transient ischemic attack and myocardial infarction, if less than 6 months old and unresolved. * History of venous thromboembolic disease, if less than 6 months old * Pregnant or breastfeeding women. * Person under guardianship, or person deprived of liberty. * Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma metastatic malignant neoplasm metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCC - hepatocellular carcinoma Metastatic cancer Metastatic tumor

Contacts and locations

Locations

  • CAC Eugène Marquis

    Rennes, France

  • CAC Gustave Roussy

    Villejuif, France

  • CAC Paoli Calmettes

    Marseille, France

  • CH HCC

    Colmar, France

  • CH Saint-Jean

    Perpignan, France

  • CHD Vendée

    La Roche-sur-Yon, France

  • CHRU Hôpitaux de Tours

    Tours, France

  • CHU

    Angers, France

  • CHU Hôtel Dieu

    Nantes, France

  • CHU Robert Debré

    Reims, France

  • Cac Icans

    Strasbourg, France

  • Centre Hospitalier

    Cholet, France

  • Centre Hospitalier

    Pau, France

  • Centre Hospitalier

    Quimper, France

  • Centre Hospitalier

    St-Malo, France

  • Centre Hospitalier

    Valence, France

  • Ch Annecy Genevois

    Pringy, France

  • Ch Duchenne

    Boulogne-sur-Mer, France

  • Chu Amiens Picardie

    Amiens, France

  • Chu Avicienne

    Bobigny, France

  • Chu Beaujon

    Clichy, France

  • Chu Brabois

    Vandœuvre-lès-Nancy, France

  • Chu Charles Nicolle

    Rouen, France

  • Chu Dupuytren

    Limoges, France

  • Chu Estaing

    Clermont-Ferrand, France

  • Chu Francois Mitterand

    Dijon, France

  • Chu Haut Leveque

    Pessac, France

  • Chu Haut-Leveque

    Pessac, France

  • Chu L'Archet

    Nice, France

  • Chu La Croix Rousse

    Lyon, France

  • Chu La Miletrie

    Poitiers, France

  • Chu La Pitie Salpetriere

    Paris, France

  • Chu La Timone

    Marseille, France

  • Chu Morvan

    Brest, France

  • Chu Rangueil

    Toulouse, France

  • Chu Saint Antoine

    Paris, France

  • Chu Saint-Eloi

    Montpellier, France

  • Chu Saint-Etienne

    Saint-Priest-en-Jarez, France

  • Privé Bordeaux Nord

    Bordeaux, France

  • Privé CONFLUENT

    Nantes, France

  • Privé HPCA

    Plérin, France

  • Privé LES BONNETTES

    Arras, France

  • Privé Saint-Joseph

    Marseille, France

  • Privé Saint-Joseph

    Paris, France

  • Privé Sainte Anne

    Strasbourg, France

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