The goal of this clinical trial is to evaluate the efficacy and safety of NRT6003 Injection compared to cTACE in patients with unresectable HCC.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
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.
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.
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGMengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGTime to Progression (TTP)
Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Time frame: Through study completion, at least 18 months
Objective Response Rate (ORR)
Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria
Time frame: 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
Time frame: 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
Time frame: Through study completion, at least 18 months
Time to Progression
Evaluated by the investigator in accordance with the mRECIST criteria
Time frame: Through study completion, at least 18 months
Localized Time to Progression
Evaluated by the investigator in accordance with the mRECIST criteria
Time frame: Through study completion, at least 18 months
Objective Response Rate
Evaluated by the investigator in accordance with the mRECIST criteria
Time frame: Through study completion, at least 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGZhongda Hospital Southeast University
Nanjing, Jiangsu, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGWest China Hospital
Chengdu, Sichuan, China
RECRUITING...and 1 more locations
Duration of Response
Evaluated by the investigator in accordance with the mRECIST criteria
Time frame: Through study completion, at least 18 months
Surgery Rate
Resection rate of liver target lesions
Time frame: From the administration to study completion, at least 18 months
Overall Survival (OS)
Based on survival follow-up information
Time frame: From the administration to study completion, at least 18 months
Changes in Tumor Biomarkers
The variation of alpha fetoprotein (AFP) levels
Time frame: 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
Time frame: Throughout the study, at least 18 months