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New radiation beads take on standard chemo for liver cancer

NCT ID NCT05016245

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

92 people

The number who actually took part.

Started

Sep 2021

Finished

Aug 2026

Lead sponsor

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

18 to 80 years

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: * ≥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

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009, China