Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere (CHEERS)

June 8, 2026 updated by: Chengdu New Radiomedicine Technology Co. LTD.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Chongqing, China
        • The First Hospital Affiliated to the Army Medical University
      • Hangzhou, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Shanghai, China
        • Zhongshan Hospital Fudan University
    • Fujian
      • Fuzhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, Fujian, China
        • Fujian Cancer Hospital
      • Fuzhou, Fujian, China
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • The second Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Jinan University
      • Guangzhou, Guangdong, China
        • The third affiliated hospital of Sun Yat-Sen University
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China
        • Zhongnan Hospital of Wuhan University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
    • Shanxi
      • Xi’an, Shanxi, China
        • Xi'an International Medical Center Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital
      • Luzhou, Sichuan, China
        • The Affiliated Hospital of Southwest Medical University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Cancer Hospital Airport Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. 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).
  2. 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.
  3. Child-Pugh score ≤ 7.
  4. Eastern Cooperative Oncology Group performance status ≤ 1.
  5. Adequate organ function.

Key Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NRT6003 Injection
Selective internal radiation therapy (SIRT) with TareSphere
Drug: NRT6003 Injection
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.
Other Names:
  • Yttrium-90 carbon microspheres
Active Comparator: cTACE
Transarterial chemoembolization
Drug: cTACE
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.
Other Names:
  • transarterial chemoembolization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
Time Frame: Through study completion, at least 18 months
Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Through study completion, at least 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Through study completion, at least 18 months
Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Through study completion, at least 18 months
Duration of Response (DOR)
Time Frame: Through study completion, at least 18 months
Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Through study completion, at least 18 months
Localized Time to Progression (localized TTP)
Time Frame: Through study completion, at least 18 months
Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Through study completion, at least 18 months
Surgery Rate
Time Frame: From the administration to study completion, at least 18 months
Resection rate of liver target lesions
From the administration to study completion, at least 18 months
Overall Survival (OS)
Time Frame: From the administration to study completion, at least 18 months
Based on survival follow-up information
From the administration to study completion, at least 18 months
Changes in Tumor Biomarkers
Time Frame: From the administration to study completion, at least 18 months
The variation of alpha fetoprotein (AFP) levels
From the administration to study completion, at least 18 months
Incidence and severity of adverse events (AE) and severe adverse events (SAE)
Time Frame: Throughout the study, at least 18 months
In accordance with NCI-CTCAE 5.0
Throughout the study, at least 18 months
Time to Progression
Time Frame: Through study completion, at least 18 months
Evaluated by the investigator in accordance with the mRECIST criteria
Through study completion, at least 18 months
Localized Time to Progression
Time Frame: Through study completion, at least 18 months
Evaluated by the investigator in accordance with the mRECIST criteria
Through study completion, at least 18 months
Objective Response Rate
Time Frame: Through study completion, at least 18 months
Evaluated by the investigator in accordance with the mRECIST criteria
Through study completion, at least 18 months
Duration of Response
Time Frame: Through study completion, at least 18 months
Evaluated by the investigator in accordance with the mRECIST criteria
Through study completion, at least 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu New Radiomedicine Technology Co. LTD.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gaojun Teng, Zhongda hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRT6003-HCC-2024
  • CTR20250792 (Other Identifier: Center for Drug Evaluation, NMPA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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