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| Name | Class |
|---|---|
| Innovent Biologics, Inc. | OTHER |
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This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer.
Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI363 + chemotherapy | Drug | IBI363+chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Up to approximately 36 months | |
| Progression-Free Survival(PFS) | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 6 months | |
| Disease control rate(DCR) | Up to approximately 6 months | |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Up to approximately 12 months |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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