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To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1:HRS-4642+NALIRIFOX | Experimental |
| |
| Arm 2:HRS-4642+NALIRIFOX+Adebrelimab(4 cycles of neoadjuvant therapy) | Experimental |
| |
| Arm 3:HRS-4642+NALIRIFOX+Adebrelimab(6 cycles of neoadjuvant therapy) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4642+NALIRIFOX | Drug | HRS-4642+NALIRIFOX |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose | |
| Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) | Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate (pCR) | At the time of surgery | |
| R0 (microscopically margin-negative) resection rate | At the time of surgery | |
| Major Pathologic Response Rate (MPR) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| HRS-4642+NALIRIFOX+Adebrelimab |
| Drug |
HRS-4642+NALIRIFOX+Adebrelimab |
|
| HRS-4642+NALIRIFOX+Adebrelimab | Drug | HRS-4642+NALIRIFOX+Adebrelimab |
|
| At the time of surgery |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |