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The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib+mFOLFIRINOX | Experimental | Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a dose limited toxicity | Number of participants with a dose limited toxicity | 28 Days (first and second cycle) |
| Maximum tolerated dose | Maximum tolerated dose | Up to 8 months |
| RP2D | Recommended Phase 2 Dose | Up to 8 months |
| R0 resection rate | R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Incidence of adverse events and associated dose of Fluzoparib | From the first drug administration to within 30 days for the last drug dose |
| Resection Rate | Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlei Jin, Ph.D | Contact | 86-021-23511999 | jinchunlei@hrglobe.cn |
| Name | Affiliation | Role |
|---|---|---|
| Boyong Shen, M.D. | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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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 |
|---|---|
| C000722917 | fluzoparib |
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| Up to 2 years |
| MPR Rate | Major pathological response rate based on central review | Up to 2 years |
| Objective response rate | Objective response rate | Up to 2 years |
| Disease-free-survival | Disease-free-survival | Up to 2 years |
| Event-Free-Survival | Event-Free-Survival | Up to 2 years |
| Overall-Survival | Overall-Survival | Up to 2 years |
| Minimum concentration (Cmin) | Minimum observed plasma concentration for Fluzoparib | Up to 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |