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

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: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma
• Intervention / Treatment: Drug: NRT6003 Injection; Drug: cTACE

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: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gaojun Teng; Phone Number: +8602583272084; Email: zdyyjgb@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Cancer Hospital
      • Principal Investigator: Jingfeng Liu
      • Contact: Jingfeng Liu
    • Fuzhou, Fujian, China
      • Recruiting
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
      • Contact: Yongyi Zeng
      • Principal Investigator: Yongyi Zeng
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou Medical University
      • Contact: Kangshun Zhu
      • Principal Investigator: Kangshun Zhu
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital
      • Principal Investigator: Hui Yang
      • Contact: Hui Yang
      • Contact: Hongtao Hu
      • Principal Investigator: Hongtao Hu
    • Zhengzhou, Henan, China
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
      • Principal Investigator: Xingmin Han
      • Contact: Wenzhi Guo
      • Contact: Xingmin Han
      • Principal Investigator: Wenzhi Guo
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Chuansheng Zheng
      • Principal Investigator: Chuansheng Zheng
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Yufeng Yuan
      • Principal Investigator: Yufeng Yuan
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
      • Contact: Gaojun Teng, MD
      • Principal Investigator: Gaojun Teng
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Haibo Shao
      • Principal Investigator: Haibo Shao
      • Contact: Xuena Li
      • Principal Investigator: Xuena Li
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital
      • Contact: Hong Wu
      • Principal Investigator: Hong Wu
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Cancer hospital Airport hospital
      • Principal Investigator: Dong Dai
      • Contact: Tongguo Si
      • Contact: Dong Dai
      • Principal Investigator: Tongguo Si

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Time to Progression (TTP)	Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria	Through study completion, at least 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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)	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)	Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria	Through study completion, at least 18 months
Surgery Rate	Resection rate of liver target lesions	From the administration to study completion, at least 18 months
Overall Survival (OS)	Based on survival follow-up information	From the administration to study completion, at least 18 months
Changes in Tumor Biomarkers	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)	In accordance with NCI-CTCAE 5.0	Throughout the study, at least 18 months
Time to Progression	Evaluated by the investigator in accordance with the mRECIST criteria	Through study completion, at least 18 months
Localized Time to Progression	Evaluated by the investigator in accordance with the mRECIST criteria	Through study completion, at least 18 months
Objective Response Rate	Evaluated by the investigator in accordance with the mRECIST criteria	Through study completion, at least 18 months
Duration of Response	Evaluated by the investigator in accordance with the mRECIST criteria	Through study completion, at least 18 months

Collaborators and Investigators

• Sponsor: Chengdu New Radiomedicine Technology Co. LTD.
• Investigators: Principal Investigator: Gaojun Teng, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Yttrium-90; Selective internal radiation therapy; Transarterial Radioembolization; Conventional Transarterial Chemoembolization
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID 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