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The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 | Experimental | SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 | Drug | PDL1/TGFβ |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| RP2D | Recommended Phase 2 Dose of SHR-1701 | Up to week 3 |
| ORR | Objective Response Rate | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant toxicity | above grade 3 AEs | Up to week 3 |
| OS rate | 9-month-overall survival rate | From the start of treatment to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China | ||||
| Fudan University Shanghai Cancer Center |
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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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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 90 days for the last SHR-1701 dose |
| PFS | Progression-Free-Survival | Up to approximately 6 months |
| DCR | Disease Control Rate | Up to approximately 12 months |
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 2 years |
| Shanghai |
| China |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |