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Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lenvatinib combined with TACE and camrelizumab | Experimental |
| |
| lenvatinib combined with TACE | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib combined with TACE and Camrelizumab | Combination Product | Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from randomization to death (any cause). | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The occurrence of any hematological or non-hematological toxicity event (≥ class Ⅲ), including but not limited to impaired liver function, impaired hematological system, hypertension, diarrhea, proteinuria, hand-foot syndrome, etc. Severity of adverse events will be graded according to CTCAE v5.0. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianfu Wen, Professor | Contact | 86-18980601471 | wentianfu@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HuaXi hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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|
| Objective response rate |
The percentage of patients achieving complete response and partial response among all patients. Response to treatment will be evaluated according to mRECIST. |
| 2 years |
| Disease control rate | The percentage of patients with complete response, partial response and stable disease among all patients. | 2 years |
| Event-free survival | Time from randomization to disease progression, local recurrence, distant metastasis, or death, whichever occurs first, assessed by mRECIST | 2 years |
| Overall survival at 2 years | The time from start of treatment until death from any cause or the end of the study (the last enrolled patient should be followed for at least 2 years | 2 years |
| Conversional resection rate | conversional resection patients/enrolled patients | 2 years |