NCT06900543

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
19mo left

Started Apr 2025

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

March 17, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

March 17, 2025

Last Update Submit

May 15, 2025

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Selective internal radiation therapyYttrium-90Transarterial RadioembolizationConventional Transarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Objective Response Rate (ORR)

    Through study completion, at least 18 months

  • Duration of Response (DOR)

    Through study completion, at least 18 months

  • Localized Time to Progression (localized TTP)

    Through study completion, at least 18 months

  • Time to Progression

    Through study completion, at least 18 months

  • Localized Time to Progression

    Through study completion, at least 18 months

  • +6 more secondary outcomes

Study Arms (2)

NRT6003 Injection

EXPERIMENTAL

Selective internal radiation therapy (SIRT) with TareSphere

Drug: NRT6003 Injection

cTACE

ACTIVE COMPARATOR

Transarterial chemoembolization

Drug: cTACE

Interventions

NRT6003 InjectionDRUG

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.

Also known as: Yttrium-90 carbon microspheres
NRT6003 Injection
cTACEDRUG

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.

Also known as: transarterial chemoembolization
cTACE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Study Officials

  • Gaojun Teng

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaojun Teng

CONTACT

+8602583272084zdyyjgb@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 28, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)