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This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune checkpoint inhibitors combined with anti-VEGF drugs | Active Comparator | Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. |
|
| Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy | Experimental | Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | ≥60 kg: 12 mg once daily, or <60 kg: 8 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR, objective response rate | 12 months after the last subject is enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| PFS, progression free survival | 12 months after the last subject is enrolled | |
| OS, overall survival | 12 months after the last subject is enrolled | |
| DCR, disease control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Feng | Contact | 86-18601989848 | fengshi0762@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39798578 | Background | Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8. |
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| Pembrolizumab | Drug | 200 mg intravenously every three weeks |
|
| Atezolizumab | Drug | 1200 mg intravenously every three weeks |
|
| Bevacizumab | Drug | 15mg/kg intravenously every three weeks |
|
| Camrelizumab | Drug | 200 mg intravenously every three weeks |
|
| Apatinib | Drug | 250mg once daily |
|
| TACE | Procedure | The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. |
|
| HAIC | Procedure | The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. |
|
| DEB-TACE | Procedure | The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. |
|
| Tislelizumab | Drug | 200 mg intravenously every three weeks |
|
| Sintilimab | Drug | 200 mg intravenously every three weeks |
|
| 12 months after the last subject is enrolled |
| DoR, duration of response | 12 months after the last subject is enrolled |
| Adverse events (AE) | 12 months after the last subject is enrolled |
| Serious adverse events (SAE) | 12 months after the last subject is enrolled |
| 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 |
| C582435 | pembrolizumab |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| C000631724 | camrelizumab |
| C553458 | apatinib |
| C000707970 | tislelizumab |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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