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This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC patients, after signing informed consent, will receive TACE treatment. Envafolimab combined with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed on demand. Patients will receive the treatment continuously until disease progression or intolerance. Tumor imaging evaluation will be performed according to RECIST V1.1 criteria every 6 weeks. Safety will be assessed with CTCAE 5.0. Adverse events throughout and within 30 days of the end of the study will be recorded (severe adverse events or adverse events associated with Envafolimab will be recorded within 90 days after the end of treatment).Treatment will last for 2 years or until disease progression, withdrawal of informed consent, loss of visit, or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Envafolimab, Lenvatinib and TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab | Drug | 300mg, subcutaneous injection, q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective reponse rate (ORR) | The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during study | Up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during study | Up to 2 years. |
| Duration of remission (DoR) | The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tingbo Liang, PhD | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39384742 | Derived | Chen Y, Zhang J, Hu W, Li X, Sun K, Shen Y, Zhang M, Wu J, Gao S, Yu J, Que R, Zhang Y, Yang F, Xia W, Zhang A, Tang X, Bai X, Liang T. Envafolimab plus lenvatinib and transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2024 Oct 9;9(1):280. doi: 10.1038/s41392-024-01991-1. |
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| ID | Term |
|---|---|
| C000718749 | envafolimab |
| C531958 | lenvatinib |
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| TACE |
| Procedure |
The first TACE will be started on d1, and the subsequent TACE will be performed on demand. |
|
| Lenvatinib | Drug | 8mg,QD (body weight <60kg); 12mg, QD (body weight ≥ 60kg) |
|
| Up to 2 years. |
| Progression-free survival (PFS) | The time from enrolled to disease pregression or death from any cause. | Up to 2 years. |
| Overall survival (OS) | The time from enrolled to death from any cause. | Up to 2 years. |
| Safety of treatment | Safety evaluation was done continuously during treatment by using CTCAE 5.0 | Up to 2 years. |