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This is a Phase 2, open-label, multicenter,study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant - Page 1 of 5 - protein) combine with IMM27M(Anti-CTLA-4 Humanized monoclonal antibody) in patients with advanced hepatocellular carcinoma who not have received the treatment for aHCC in past
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants will receive IMM2510 20.0 mg/kg(Q2W), will receive IMM27M 1.0 mg/kg (Q8W) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM2510, IMM27M | Drug | Biological/Vaccine: IMM2510 IMM2510 administered intravenously once every 2 weeks ( 20 mg/kg Q2W). Biological/Vaccine: IMM01 IMM01 administered intravenously once every 2 weeks ( 1 mg/kg Q8W). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate(DCR) | From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years | |
| Duration of Response (DOR) |
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Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Exclusion Criteria:
History of other malignancy within the past 5 years with exceptions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianxin Liu | Contact | +86 0551-62284121 | liulx@ustc.edu.cn |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years |
| Progression- Free Survival(PFS) | From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years. |
| Overall Survival(OS) | From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years. |
| Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0) | From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment |
| Maximum Plasma Concentration [Cmax] | through study completion, an average of 1 year |
| Area Under the Curve from time 0 to time t（AUC0-t） | through study completion, an average of 1 year |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |