New combo therapy aims to boost liver cancer survival
NCT ID NCT06999694
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new combination treatment for people with advanced liver cancer that cannot be removed by surgery. It combines precise proton radiation with two immunotherapy drugs, tremelimumab and durvalumab. The goal is to see if this approach is safe and works better than current treatments. About 45 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton radiotherapy, tremelimumab, and durvalumab
- What this could lead to
- If successful, this combination could offer a more effective treatment option for advanced liver cancer, potentially improving survival and tumor control.
- What could go wrong
- This is an early phase 2 trial with only 45 participants, so results may not apply to everyone. Side effects from the drugs and radiation can be serious.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2033
An estimate. End dates often move.
- Lead sponsor
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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
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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: 1. Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of \< 20 cm, and no one lesion \> 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below: * Histologically or cytologically proven diagnosis of HCC. * Typical arterial enhancement and delayed washout on multiphasic CT or MRI. 2. Age ≥18 years at the time of signing informed consent document. 3. ECOG performance status 0-1. 4. Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C). 5. Child-Pugh score 5-6 liver function within 28 days of study registration. 6. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test. 7. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test. 8. Ability to understand and the willingness to sign a written informed consent document 9. Adequate bone marrow, liver, and renal function within 4 weeks before 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) ≤ 3 × upper limit of normal (ULN) * Prothrombin time ≤ 6 seconds prolonged * Serum creatinine ≤ 1.5 mg/dL Exclusion Criteria: 1. Prior invasive malignancy unless disease free for a minimum of 2 years 2. Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields 3. Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time 4. Untreated active hepatitis B or hepatitis C 5. Moderate to severe or intractable ascites 6. Presence of distant metastases that cannot be encompassed by proton radiotherapy 7. Untreated or incomplete treated esophageal or gastric varices 8. Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration * Myocardial infarction within the last 6 months prior to study entry * Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry * A bleeding episode within 6 months prior to study entry due to any cause. * Thrombolytic therapy within 28 days prior to study entry. * Known bleeding or clotting disorder. * Uncontrolled psychotic disorder 9. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception 10. Prior solid organ transplantation. 11. Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis. 12. Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation. 13. Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints cannot be met for covering all sites of liver tumors using proton radiotherapy.) 14. Known HIV infection.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chang Gung Memorial Hospital at Linkou
RECRUITINGTaoyuan City, Taiwan, 333, Taiwan
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