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The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC plus Lenvatinib and PD-1 inhibitors | Each patient should receive at least 2 cycles of HAIC, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months. |
| |
| Lenvatinib plus PD-1 inhibitors | Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatic artery infusion chemotherapy | Procedure | Hepatic arterial infusion chemotherapy including FOLFOX and RALOX |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The OS is defined as the time from the initiation of any combination treatment to death due to any cause. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) (Overall) | The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Progression free survival(PFS) of intra-hepatic lesions |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with high tumor burden advanced HCC with PVTT who received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.
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| Name | Affiliation | Role |
|---|---|---|
| Haibo Shao | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of China medical university | Shenyang | Liaoning | 110000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40930561 | Derived | Liu J, Zhang S, Shao H. Hepatic arterial infusion chemotherapy plus lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors as first-line treatment for hepatocellular carcinoma with high tumour burden and portal vein tumour thrombus (CHANCE 2416): study protocol of a multicentre, retrospective, target trial emulation design. BMJ Open. 2025 Sep 9;15(9):e099510. doi: 10.1136/bmjopen-2025-099510. |
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| Lenvatinib + PD-1 monoclonal antibody | Drug | PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab |
|
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first. |
| Up to approximately 2 years |
| Progression free survival(PFS) of extra-hepatic lesions | The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Progression free survival(PFS) of portal vein tumor thrombus (PVTT) | The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Objective response rate(ORR) per RESCIST 1.1 | The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1. | Up to approximately 2 years |
| ORR per mRECIST | The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST. | Up to approximately 2 years |
| ORR of PVTT | The ORR is defined as the proportion of patients with a documented CR or PR of PVTT. | Up to approximately 2 years |
| Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 | The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0. | Up to approximately 2 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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