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Unresectable Hepatocellular CarcinomaPhase 3CHEERSNCT06900543

Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere

A Phase 3 study testing NRT6003 Injection and cTACE in people with Unresectable Hepatocellular Carcinoma, run by Chengdu New Radiomedicine Technology Co. LTD. at 19 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
NRT6003 Injection and cTACE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
19 sitesChina
Study dates
15 Apr 2025to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed as hepatocellular carcinoma (CNLC Ⅰa-Ⅲa) clinically, by imaging and/or pathology based on the guideline of the National Health Commission of the People's Republic of China (2024).
  • Evaluated by the investigator as not suitable for surgical resection/ablation/liver transplantation, or there is high risk for surgical resection, or the participant refuses surgical resection/ablation/liver transplantation.
  • Child-Pugh score ≤ 7.
  • Eastern Cooperative Oncology Group performance status ≤ 1.
  • Adequate organ function.

Who cannot join

  • Imaging evidence or suspicion of extrahepatic metastases (including regional lymph node metastases).
  • Prior antitumor treatment for primary hepatocellular carcinoma.
  • Prior external radiation therapy or intra-arterial brachytherapy.
  • Liver vascular evaluation results that do not meet all the requirements of the study.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • West China Hospital

    Chengdu, Sichuan

  • The First Hospital Affiliated to the Army Medical University

    Chongqing

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Zhongshan Hospital Fudan University

    Shanghai

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Xi'an International Medical Center Hospital

    Xi’an, Shanxi

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Open-label, Multicenter Study Comparing the Efficacy and Safety of NRT6003 Injection With Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)

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

Read the detailed description

The main questions it aims to answer are:

  1. Does NRT6003 Injection improve tumor response rates compared to cTACE in patients with unresectable HCC?
  2. What adverse events do participants experience when receiving NRT6003 Injection compared to cTACE?

Investigators will compare NRT6003 Injection to cTACE to determine:

  1. Whether NRT6003 Injection demonstrates superior efficacy in tumor control and long-term survival (e.g., objective response rate, time to progression, etc.).
  2. Whether NRT6003 Injection has a comparable or improved safety profile vs. cTACE (e.g., incidence of adverse events, etc.).

Participants will:

  1. Receive either NRT6003 Injection or cTACE as per randomized assignment.
  2. Undergo scheduled follow-up visits for imaging assessments (e.g., MRI or CT scans, etc.) and safety evaluations.
  3. Provide blood samples for biomarker analysis.
  4. Report any symptoms or medical events through a patient diary and during clinic visits.
Being tested
NRT6003 Injection, cTACE
Keywords
Selective internal radiation therapy, Yttrium-90, Transarterial Radioembolization, Conventional Transarterial Chemoembolization

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

    Patients will be administered NRT6003 Injection via Intra-arterial infusion, and subsequently they will be assessed by PET/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.

  • cTACEDrug

    Also called transarterial chemoembolization

    Patients will receive cTACE treatment. And the investigators will select one or more chemotherapy drugs in combination with embolic materials for administration, based on the specific condition of the patient.

Study groups in NCT06900543
Study groupRoleWhat they receive
NRT6003 InjectionExperimentalSelective internal radiation therapy (SIRT) with TareSphere
Receives: Drug: NRT6003 Injection
cTACEActive comparatorTransarterial chemoembolization
Receives: Drug: cTACE

What is being measured

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

  1. Time to Progression (TTP)

    Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  2. Duration of Response (DOR)

    Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  3. Localized Time to Progression (localized TTP)

    Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  4. Time to Progression

    Evaluated by the investigator in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  5. Localized Time to Progression

    Evaluated by the investigator in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  6. Objective Response Rate

    Evaluated by the investigator in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  7. Duration of Response

    Evaluated by the investigator in accordance with the mRECIST criteria

    Measured: Through study completion, at least 18 months

  8. Surgery Rate

    Resection rate of liver target lesions

    Measured: From the administration to study completion, at least 18 months

  9. Overall Survival (OS)

    Based on survival follow-up information

    Measured: From the administration to study completion, at least 18 months

  10. Changes in Tumor Biomarkers

    The variation of alpha fetoprotein (AFP) levels

    Measured: From the administration to study completion, at least 18 months

  11. Incidence and severity of adverse events (AE) and severe adverse events (SAE)

    In accordance with NCI-CTCAE 5.0

    Measured: Throughout the study, at least 18 months

Timeline

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

  1. First posted28 Mar 2025
  2. Study start15 Apr 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06900543
Sponsor's protocol ID
NRT6003-HCC-2024
Other IDs
CTR20250792
Acronym
CHEERS
Status last verified
Jun 2026
First submitted
17 Mar 2025
Last updated
9 Jun 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 3 study testing NRT6003 Injection and cTACE in people with Unresectable Hepatocellular Carcinoma, run by Chengdu New Radiomedicine Technology Co. LTD. at 19 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 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?

This study is still under way. Results are not available in the source record yet.

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, at least 18 months). 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 NCT06900543.

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 9 Jun 2026.

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