New radiation beads take on standard chemo for liver cancer
NCT ID NCT05016245
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times
Summary
This study compares a new treatment called TheraSphere (tiny radioactive beads) to standard chemoembolization for people with liver cancer that cannot be removed by surgery. About 92 Chinese adults with early-to-mid stage liver cancer will be randomly assigned to one of the two treatments. The goal is to see which approach better delays tumor growth and has fewer side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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92 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Aug 2026
- Lead sponsor
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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
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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: * ≥18 and ≤80 age and provided study consent * Patients diagnosed with HCC and clinically evaluated as inoperable (as per local practice) or who refuse operation (ablation, hepatectomy and liver transplantation) * At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI * China liver cancer staging (CNLC) stage Ib\~IIb * Child-Pugh ≤ B7 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Tumor burden ≤50% of the total liver volume Exclusion Criteria: * Presence of extra-hepatic metastases or additional malignancies aside from HCC * Patients with hepatic artery malformation and unable to intubate hepatic artery * Patients who are allergic to contrast agents or have renal insufficiency (Serum creatinine\>2mg/ml or Creatinine clearance\<30mL/min) and are not suitable for injection of contrast agents * Severe pulmonary insufficiency (FEV1/FVC\<50% or FEV1/predicting value\<50% or MVV\<50L/min) * AST and ALT \>5 times upper limit of normal * Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites, gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical Practice Guidelines) * HCC invading biliary tract or causing biliary obstruction * uncorrectable coagulation dysfunction and severe hemogram abnormality \[Prothrombin time (PT)\>6 seconds above control or PT-International normalized ratio (INR)\>2.5, WBC\<3.0x109/L, PLT\<50x109/L\] * Infiltrative HCC tumor type * Bilobar HCC disease * Any presence of portal vein or hepatic veins or artery invasion * Occlusion of portal vein completely with less collateral vessels * Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal fistula * Patients during pregnancy or lactation * Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques * Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment or greater than 50Gy in multiple treatment * The absorbed dose of lung may exceed 30Gy in preoperative evaluation * Receive any investigational therapy or anti-tumor therapy within 30 days prior to study enrollment * Any other reason in which the investigator believes that the patient is unsuitable to participate in this trial
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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
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China