New trial tests which radiation combo best fights liver cancer
NCT ID NCT07293468
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This clinical trial compares two types of radiation therapy—SBRT and SIRT—each combined with immunotherapy, for people with advanced liver cancer that cannot be removed by surgery. About 106 participants will be randomly assigned to one of the two treatments. The goal is to see which approach provides longer control of the cancer with similar side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (SBRT or SIRT) plus immunotherapy
- What this could lead to
- If successful, this could identify a more effective radiation approach to control advanced liver cancer when combined with immunotherapy, potentially extending life without progression.
- What could go wrong
- This is a mid-stage trial with only 106 participants, so results may not apply to all patients. Both treatments carry risks like liver damage or side effects from radiation and immunotherapy.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2034
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 to 80 years
- 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: * Patients diagnosed with HCC either by histology or by the American Association for the Study of Liver Diseases Criteria (AASLD) 2018 * Patients age 18-80 years of age with HCCs deemed unresectable at the Multidisciplinary Team Meetings (MDTs) because of the following: * R0 resection not feasible e.g. unfavourable tumour location * Remnant liver volume \<30% in non-cirrhotic patients or 40% in cirrhotic patients * Indocyanine green test \>15% * Patients with Barcelona Clinic Liver Cancer (BCLC) stage B2-4 (unresectable group) or C * Tumour sizes of ≥5cm, of which ≥1 is a measurable lesion as defined by the mRECIST criteria * Subjects aged 18-80 years of age * ECOG performance status of 0-1 * Predicted life expectancy should be of ≥ 3 months * Child Pugh (CP) score of A5-B7 * Adequate organ and marrow functions, as listed below: * Haemoglobin ≥9 g/dL * Absolute neutrophil count ≥1,500/uL * Platelet count ≥100,000/L * Total bilirubin ≤2.0 x upper limit of normal (ULN) * Albumin ≥2.8 g/dL * ALT ≤3 x ULN * INR ≤1.6 * Calculated creatinine clearance (eGFR) ≥45 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance * Liver volume minus intrahepatic gross tumour volume (GTV) with \>700cc * Patients with concomitant HBV infection (defined as having HBsAg positive and/or detectable HBV DNA level) must be treated with antiviral therapy (per local institutional practice) to ensure adequate viral suppression (defined as HBV DNA \<2,000 IU/mL) prior to enrolment, throughout study duration and continue for at least 6 months following the last dose of local-systemic therapy * Informed consent provided * Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception * Females of childbearing potential must have negative serum or urine pregnancy test Exclusion Criteria: * Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured * Presence of any extra-hepatic metastases * Presence of main portal vein (PV) or inferior vena cava (IVC) involvement * Presence of active, uncontrolled varices * Presence of active, severe comorbidities including uncontrolled cardiovascular or cerebrovascular diseases or recent events within 6months prior to treatment * Received prior non-curative locoregional (including TACE, RT to liver, SIRT) or systemic therapy received for HCC\\ * Prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent, or an antibody targeting other immune-regulatory receptor(s) or mechanism(s) * Use of chronic systemic steroid or any other immunosuppressive medication within 14days prior to treatment initiation, except: * Intranasal, inhaled, topical steroids, or local steroid injection; * Systemic corticosteroids at physiologic doses ≤10mg/day of prednisone or equivalent; * Steroids as premedication for hypersensitivity reactions * Active or documented autoimmune or inflammatory disorders within 2years, except diabetes type I, vitiligo, psoriasis, or hypo-/hyperthyroid diseases not requiring immunosuppressant(s) * Known history of a positive HIV test, primary/acquired immunodeficiency syndrome, or solid organ transplantation * Receipt of live, attenuated vaccine within 28 days prior to study treatment * Severe hypersensitivity reaction to another monoclonal antibody * Presence of any contraindication to TACE not otherwise listed: cisplatin allergy * Presence of any contraindication to SBRT not otherwise listed: * Maximal size of any one HCC \>25 cm * Direct tumour extension into gastrointestinal structures (stomach, duodenum, remaining small or large bowel) * Presence of any contraindication to SIRT not otherwise listed: * Pre-treatment 99mTc-MAA scan \>20% lung shunting of hepatic artery blood flow, or a demonstration of radiation exposure to the lungs potentially \>25Gy * Pre-treatment hepatic angiogram showing potential Y90 microspheres deposition in the gastrointestinal tract or any other organ(s) which is not correctable by catheter embolization techniques. * Pregnant or lactating females
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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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Tuen Mun Hospital
RECRUITINGHong Kong, Hong Kong
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Other studies related to the condition(s) this trial covers.
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- Can a smart drug starve liver tumors without harming healthy tissue?
- Liver size may hold key to immunotherapy response
- Can a new model forecast liver cancer in hepatitis b?