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This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NALIRI-XELOX+AK104 | Experimental | Every 2 weeks as a cycle:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab | Drug | Use the above medications on a regular basis |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR of regimen of NALIRI-XELOX+AK104 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | 2 years | |
| Disease Control Rate (DCR) | 2 years | |
| Median Progression-Free Survival (mPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lin yang | Contact | 13611267380 | linyangcicams@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| 1 years |
| 12-month PFS rate | 12 months |
| Median Overall Survival (mOS) | 2 years |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence | 2 years |