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
| Name | Class |
|---|---|
| Affiliated Hospital of Nantong University | OTHER |
| Nantong First People's Hospital | OTHER |
| The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTAC Group | Experimental | Patients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy. |
|
| HAC Group | Experimental | Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab. |
|
| TAC Group | Experimental | Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTAC | Procedure | Patients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) [Assessed by mRECIST Criteria] | Definition: The time from enrollment to tumor progression or death from any cause. Assessment: Evaluated and judged by the investigator based on the mRECIST criteria. | Up to 27 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria] | The proportion of patients with objective tumor response, as evaluated by the investigator using both mRECIST and RECICL criteria, including cases of complete response (CR) and partial response (PR). | Up to 27 months |
| Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria] |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Indicators [Including Incidence and Severity of Adverse Events (AE), Serious Adverse Events (SAE), and Abnormal Laboratory Values] | Evaluation Standard: Judged in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. | Up to 27 months. |
Inclusion Criteria
Exclusion Criteria
Withdrawal Criteria
Key Terminology Notes
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Shandong Public Health Clinical Center | OTHER_GOV |
| Shanghai Xuhui Hospital | UNKNOWN |
| The fifth Hospital Affiliated To WZMU | UNKNOWN |
Not provided
Not provided
Not provided
This study adopts a single-blind design, where subjects and staff responsible for subject recruitment and management are aware of the study group assignments and arrange corresponding screening interventions, while physicians conducting clinical examinations for subjects are unaware of the subjects' group allocations.
|
| HAC | Procedure | Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab. |
|
| TAC | Procedure | Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab. |
|
The proportion of patients with controlled tumor disease, as evaluated by the investigator using both mRECIST and RECICL criteria, including cases of complete response (CR), partial response (PR), and stable disease (SD) (lasting for more than 4 weeks) |
| Up to 27 months |
| Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria] | Definition: The time from the first assessment of complete response (CR) or partial response (PR) to the first assessment of progressive disease (PD) or death from any cause. Assessment: Evaluated and judged by the investigator based on both RECICL and mRECIST criteria. | Up to 27 months |
| Overall Survival (OS) | The time from enrollment to death from any cause. | Up to 27 months |
| Progression-Free Survival (PFS) [Assessed by RECIST Criteria] | Definition: The time from enrollment to tumor progression or death from any cause. Assessment: Evaluated and judged by the investigator based on the RECICL criteria. | Up to 27 months. |
| D008107 |
| Liver Diseases |