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New combo therapy shows promise for tough-to-treat liver cancer

NCT ID NCT05625893

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a combination of proton beam radiotherapy followed by two drugs (Tecentriq and Avastin) in 63 adults with advanced liver cancer that had spread into the portal vein. The goal was to see if this approach could help control the cancer and improve survival. Participants had not received prior systemic therapy. The study measured how long patients lived without the cancer getting worse and tracked side effects.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Jan 2023

Finished

Mar 2026

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

20 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: * Patients with HCC meeting all of following criteria; 1. Histologically or radiologically confirmed hepatocellular carcinoma based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 2022 2. Age \>= 20 3. Vp2-4 portal vein tumor thrombosis diagnosed by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI) with below finding 1) an intraluminal filling defect adjacent to the primary tumor in Vp2-4 portal vein 2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases. 4. Signed written informed consent 5. at least one or more measurable intrahepatic viable HCC lesions 6. Child-Pugh class A within 2 weeks from screening for study registration 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 2 weeks from screening for study registration 8. Life expectancy of at least 16 weeks 9. adequate bone marrow and liver function within 2 weeks from screening for study registration * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelet count ≥ 50,000/μL * Total bilirubin \< 2.5 mg/dL * Serum albumin \>2.8 g/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN) * Prothrombin time in INR ≤ 1.8 × ULN * Serum creatinine ≤ 1.5 mg/dL 10. Women of childbearing potential and men must agree to use highly efficient contraception since signing of the informed consent form until at least 6 months (women) and 7 months (men) after the last study drug administration 11. If other selection conditions are satisfied and the exclusion criteria are not met, registration is possible even in case of N1 or M1. 12. Registration is possible even in the case of hepatic vein tumor infiltration if other selection conditions are satisfied and the exclusion criteria are not met 13. no limitation according to the size and number of tumors in the liver. Exclusion Criteria: Patients with HCC meeting all of following criteria; 1. previous history of systemic treatment for HCC (If systemic treatment for HCC has been performed at least once, it will not be enrolled in this study.) However, registration is permitted if the previous systemic treatment is for adjuvant purposes or treatment for other cancers. Also allowed if previous HCC treatment is local treatment. However, cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded. 2. any type of anticancer agent (including investigational) within 2 weeks before enrollment 3. Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy 4. Moderate to severe or intractable ascites 5. A history or presence of hepatic encephalopathy 6. Presence of active bacterial infection 7. Untreated active chronic hepatitis B or active hepatitis C 8. History of portal hypertension with bleeding within the past 6 months 9. Prior liver transplant 10. Uncontrolled severe medical comorbidity 11. unhealed wound 12. uncontrolled electrolyte imbalance 13. Non-interruptible therapeutic use of anticoagulants or thrombolytics 14. History of uncontrolled or autoimmune disease, or immunocompromised 15. interstitial lung disease 16. Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years) 17. Mentally retarded/medically incapable of consent

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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

  • Samsung Medical Center

    Seoul, 06351, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.