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Unresectable Hepatocellular CarcinomaPhase 1NCT06310590

Safety and Efficacy of TareSphere in Patients With Unresectable Hepatocellular Carcinoma

A Phase 1 study testing NRT6003 Injection in people with Unresectable Hepatocellular Carcinoma, run by Chengdu New Radiomedicine Technology Co. LTD. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
NRT6003 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesChina
Study dates
8 Aug 2023to 10 Jun 2025
Phase
Phase 1
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

  • Aged 18 to 80 and signed informed consent;
  • Diagnosed as hepatocellular carcinoma clinically, by imaging and/or pathology based on the guideline of the National Health Commission of the People's Republic of China (2022);
  • Evaluated by the investigator as not suitable for surgical resection/ablation, or there are other reasons unsuitable for surgical resection/ablation, or the participant refuses surgical resection/ablation;
  • At least one well defined tumor (mRECIST), assessed by enhanced MRI or CT images;
  • Child-Pugh score ≤ 7;
  • Eastern Cooperative Oncology Group performance status ≤ 1;
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  • Tumor burden ≤ 50 percent of the total liver volume;
  • Adequate organ function: (1) Blood routine [no blood transfusion or granulocyte colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelet (PLT) ≥ 80 × 10^9/L; hemoglobin (HGB) ≥ 90 g/L; (2) Liver function: total bilirubin (TBIL) ≤ 2 times upper limit of normal (ULN); alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5. 0×ULN; Albumin > 30 g/L; (3) Renal function: Creatinine (Cr) ≤ 1.5×ULN; creatinine clearance rate (CCr)≥ 50 mL/min (calculated according to Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN [If any participant takes warfarin or heparin for anticoagulation therapy, the investigator should evaluate whether the participant meet the requirements of the protocol]; (5) Cardiovascular function: left ventricular ejection fraction (LVEF) ≥ 50 percent assessed by ultrasonic cardiogram;
  • Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 months after the end of the trial. Men are forbidden to donate sperm. The pregnancy test results of female participants of childbearing age during the screening period and within 24 hours before administration must be negative.

Who cannot join

  • With the extrahepatic metastasis or concurrent malignant tumors other than liver cancer;
  • With the hepatic tumor thrombus (excluding the thrombus limited to liver segments or lobes);
  • With hepatic artery malformation and unable to intubate hepatic artery;
  • Allergy to contrast agents or anesthetics;
  • Severe pulmonary dysfunction (forced expiratory volume in one second, FEV1/FVC < 50 percent or forced expiratory volume in one second (FEV1) < 50 percent of predicted value, or maximum voluntary ventilation (MVV) < 50 L/min);
  • With the clinical manifestations of decompensated liver cirrhosis (moderate or severe ascites, upper gastrointestinal bleeding, hepatic encephalopathy, etc.);
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  • With diseases have not been controlled despite aggressive treatment, and which may affect the safety or the efficacy of the investigational drug in the judgement of investigators;
  • Active or severely infected participants requiring systemic therapy;
  • With positive results of HIV antibody test;
  • Estimated survival period < 3 months;
  • Have received radiotherapy or transcatheter arterial chemoembolization (participants who have received transcatheter arterial non-iodized oil chemoembolization are judged by investigators);
  • Technetium (99mTc)-macroaggregated albumin (MAA) hepatic arterial perfusion imaging estimates that the NRT6003 injection cannot cover all lesions within the liver (excluding lesions previously treated by the investigator as non-active or non-progressive);
  • Hepatic artery angiography and 99mTc-MAA hepatic artery perfusion imaging demonstrate gastrointestinal shunts, which may not be remedied through vascular intervention techniques;
  • 99mTc-MAA arterial perfusion imaging shows that the single lung radiation absorbed dose > 30 Gy;
  • Received antitumor therapy or participated in other interventional clinical trials within 30 days prior to dosing;
  • Pregnant or lactating women;
  • Have persistent, unrelieved toxicity reaction of CTCAE≥2 grade caused by previous antitumor treatment (excluding alopecia) judged by investigators;
  • Any other reason that the investigator deems the participant unsuitable for participating in this trial.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Hospital

    Hefei, Anhui

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

  • Zhongshan Hospital, Fudan University

    Shanghai

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Study on the Safety and Effectiveness of NRT6003 Injection in Patients With Unresectable Hepatocellular Carcinoma (HCC)

The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC.

Read the detailed description

The efficacy and safety of TareSphere in patients with unresectable HCC remains unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6003 injection.

The primary objective is to evaluate the safety of NRT6003 Injection. While the secondary objectives include the assessments of the antitumoral efficacy, the improvement of patients´ quality of life, and the distribution characteristics of Yttrium-90 in body.

Being tested
NRT6003 Injection
Keywords
Selective internal radiation therapy, Yttrium-90, Transarterial Radioembolization;

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRT6003 InjectionDrug

    Also called Yttrium-90 carbon microspheres

    Selective internal radiation therapy (SIRT) with TareSphere

Study groups in NCT06310590
Study groupRoleWhat they receive
NRT6003 InjectionExperimentalPatients will be administered a single dose of NRT6003 Injection, and then they will be assessed by SPECT-CT imaging within 24 hours for its distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected. Nine Patients will be tested for the radioactivity of Yttrium-90 in blood, urine, and feces (if available).
Receives: Drug: NRT6003 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events/ Severe adverse events

    Occurrence of adverse events/severe adverse events

    Measured: Up to 12 months

  2. Localized Objective response rates (ORR)

    Liver target lesions, evaluated based on the mRECIST criteria

    Measured: Up to 6 months (initial tumor assessment after administration)

Secondary outcomes (10)

  1. Hepatic time to progression (hTTP)

    Time to progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST)

    Measured: Up to 12 months

  2. Duration of response (DOR)

    Time without imaging progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

    Measured: Up to 12 months

  3. Disease control rate (DCR)

    Time without imaging progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

    Measured: Up to 12 months

  4. Time to progression (TTP)

    Time with tumor progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

    Measured: Up to 12 months

  5. Progression Free Survival (PFS)

    Duration from the administration to the first evidence of progression or death from any cause, evaluated by the investigator and independent image review committee respectively (mRECIST)

    Measured: Up to 12 months

  6. Concentration of Alpha fetoprotein (AFP)

    The variation of AFP levels

    Measured: Up to 12 months

  7. Quality of life (QoL)

    The variation of QoL with the EORTC (European organization for Research and Treatment of Cancer) QLG (Quality of Life Group) Core Questionnaire (EORTC QLQ-C30)

    Measured: Up to 12 months

  8. Yttrium-90 distribution

    Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.

    Measured: Within 24 hours

  9. Resection rate of liver target lesions

    Resection rate of liver target lesions

    Measured: Within 6 months after administration

  10. Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter

    Detect the radioactivity of Yttrium-90 in blood, urine, and feces (if available) in liquid scintillation counter

    Measured: Within 168 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start8 Aug 2023
  3. Primary completion10 Jun 2025
  4. Study completion10 Jun 2025

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310590
Sponsor's protocol ID
NRT6003-HCC-2022
Other IDs
CTR20230515
Status last verified
Dec 2025
First submitted
26 Feb 2024
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NRT6003 Injection in people with Unresectable Hepatocellular Carcinoma, run by Chengdu New Radiomedicine Technology Co. LTD. at 10 sites 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 9 inclusion and 18 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Adverse events/ Severe adverse events (time frame: Up to 12 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?

On the ClinicalTrials.gov record for NCT06310590.

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 3 Feb 2026.

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