Unresectable Hepatocellular Carcinoma
Conditions
Keywords
Selective internal radiation therapy, Yttrium-90, Transarterial Radioembolization, Conventional Transarterial Chemoembolization
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.
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.
Interventions
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.
DRUGcTACE
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.
Sponsors
Chengdu New Radiomedicine Technology Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP) | Through study completion, at least 18 months | Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Through study completion, at least 18 months | Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria |
| Localized Time to Progression (localized TTP) | Through study completion, at least 18 months | Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria |
| Time to Progression | Through study completion, at least 18 months | Evaluated by the investigator in accordance with the mRECIST criteria |
| Localized Time to Progression | Through study completion, at least 18 months | Evaluated by the investigator in accordance with the mRECIST criteria |
| Objective Response Rate | Through study completion, at least 18 months | Evaluated by the investigator in accordance with the mRECIST criteria |
| Objective Response Rate (ORR) | Through study completion, at least 18 months | Evaluated by the Blinded Independent Review Committee (BIRC) in accordance with the mRECIST criteria |
| Surgery Rate | From the administration to study completion, at least 18 months | Resection rate of liver target lesions |
| Overall Survival (OS) | From the administration to study completion, at least 18 months | Based on survival follow-up information |
| Changes in Tumor Biomarkers | From the administration to study completion, at least 18 months | The variation of alpha fetoprotein (AFP) levels |
| Incidence and severity of adverse events (AE) and severe adverse events (SAE) | Throughout the study, at least 18 months | In accordance with NCI-CTCAE 5.0 |
| Duration of Response | Through study completion, at least 18 months | Evaluated by the investigator in accordance with the mRECIST criteria |
Countries
China
Contacts
Primary ContactGaojun Teng
Outcome results
None listed