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This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy
This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimtuzumab combined ICIs | Experimental | Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimtuzumab:400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objtective reseponse rate) | (Objtective reseponse rate) | up to 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| OS(overall survival) | Time from the first dose to death | up to 24 month |
| PFS(pregression free survival) | time form fist dose to tumor progression or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuntao Gao, Dr | Contact | 022-2340123 | 022-2340123 | gaochuntao@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Jihui Hao, Dr | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| ICIs(Immune checkpoint inhibitors) | Drug | Use it as it is describe in the instructions from the specification |
|
|
| up to 24 month |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |