Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20250792 | Other Identifier | Center for Drug Evaluation, NMPA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Investigators will compare NRT6003 Injection to cTACE to determine:
Participants will:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRT6003 Injection | Experimental | Selective internal radiation therapy (SIRT) with TareSphere |
|
| cTACE | Active Comparator | Transarterial chemoembolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRT6003 Injection | Drug | 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. |
| 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 |
| 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) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gaojun Teng | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | China | |||
| Mengchao Hepatobiliary Hospital of Fujian Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| cTACE | Drug | 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. |
|
|
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 |
| 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 |
| 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 |
| Fuzhou |
| Fujian |
| China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | China |
| Xi'an International Medical Center Hospital | Xi’an | Shanxi | China |
| West China Hospital | Chengdu | Sichuan | China |
| The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | China |
| Tianjin Cancer Hospital Airport Hospital | Tianjin | Tianjin Municipality | China |
| The First Hospital Affiliated to the Army Medical University | Chongqing | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | China |
| Zhongshan Hospital Fudan University | Shanghai | China |