Inoperable Hepatocellular CarcinomaPhase 3NCT05016245
MANDARIN (S6371)
A Phase 3 study testing TheraSphere™ Yttrium-90 Glass Microspheres and conventional Transarterial Chemoembolization(cTACE) in people with Inoperable Hepatocellular Carcinoma, run by Boston Scientific Corporation at 1 site in China.
Trial summary
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inoperable Hepatocellular Carcinoma
- What is being tested?
- TheraSphere™ Yttrium-90 Glass Microspheres and conventional Transarterial Chemoembolization(cTACE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2021to 10 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Prospective, Open-label, Randomized Controlled Trial on the Efficacy and Safety of TheraSphereTM (Yttrium-90 Glass Microspheres) Compared to Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Inoperable Hepatocellular Carcinoma
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
- Conditions
- Inoperable Hepatocellular Carcinoma
- Being tested
- TheraSphere™ Yttrium-90 Glass Microspheres, conventional Transarterial Chemoembolization(cTACE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere™ Yttrium-90 Glass MicrospheresCombination product
TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq.
TheraSphereTM is supplied with the following accessories:
Administration Set Administration Accessory Kit
conventional Transarterial Chemoembolization(cTACE)Procedure or surgery
conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice.
| Study group | Role | What they receive |
|---|---|---|
| TheraSphere™ Yttrium-90 Glass Microspheres | Experimental | Not described Receives: Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres |
| conventional Transarterial Chemoembolization(cTACE) | Active comparator | Not described Receives: Procedure: conventional Transarterial Chemoembolization(cTACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
Measured: through study completion, an average of 18 months
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Measured: within 60 days post treatment
Secondary outcomes (6)
Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)
Measured: through study completion, an average of 18 months
Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)
Measured: through study completion, an average of 18 months
Confirmed ORR according to mRECIST
Measured: through study completion, an average of 18 months
OS (Overall Survival)
Measured: through study completion, an average of 18 months
Safety assessed using NCI-CTCAE v 5.0
Safety assess: to standardize reporting, the National Cancer Institute Common Terminology Criteria (NCI CTCAE), version 5, was used to grade AEs and SAEs. Grades 1, 2, 3, and 4 represented mild, moderate, severe, and life-threatening toxicity, respectively. Grade 5 represented toxicity resulting in death. Descriptive analyses were conducted to assess the safety in each grade and summarized as the number of events and rate per subject.
Measured: through study completion, an average of 18 months
Procedure technical success
Procedure technical success is determined successfully if all three items are satisfied at the same time during the operation as follow:
- Device connected successfully or not;
- Microspheres or anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). deliver to target area well, or not by device parts;
- There was no unplanned release of radiation or leakage of neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s), or not by device parts.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start13 Sep 2021
- Primary completion13 Feb 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaojun TENG, Dr., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016245
- Sponsor's protocol ID
- S6371
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Open-label, Randomized Controlled Trial on the Efficacy and Safety of TheraSphereTM (Yttrium-90 Glass Microspheres) Compared to Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Inoperable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05016245
- Acronym / sponsor ID
- S6371
- Conditions
- Inoperable Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TheraSphere™ Yttrium-90 Glass Microspheres | Experimental | Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres |
| conventional Transarterial Chemoembolization(cTACE) | Active comparator | Procedure: conventional Transarterial Chemoembolization(cTACE) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphere™ Yttrium-90 Glass MicrospheresTheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq. TheraSphereTM is supplied with the following accessories: Administration Set Administration Accessory Kit | Combination product | TheraSphere™ Yttrium-90 Glass Microspheres |
| conventional Transarterial Chemoembolization(cTACE)conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice. | Procedure or surgery | conventional Transarterial Chemoembolization(cTACE) |
Primary outcome
Time to progression (TTP)
Time frame: through study completion, an average of 18 months
Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Time frame: within 60 days post treatment
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
6 secondary outcomes
Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)
Time frame: through study completion, an average of 18 months
Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)
Time frame: through study completion, an average of 18 months
Confirmed ORR according to mRECIST
Time frame: through study completion, an average of 18 months
OS (Overall Survival)
Time frame: through study completion, an average of 18 months
Safety assessed using NCI-CTCAE v 5.0
Time frame: through study completion, an average of 18 months
Procedure technical success
Time frame: immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaojun TENG, Dr. principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TheraSphere™ Yttrium-90 Glass Microspheres and conventional Transarterial Chemoembolization(cTACE) in people with Inoperable Hepatocellular Carcinoma, run by Boston Scientific Corporation at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (TTP) (time frame: through study completion, an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.