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The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.
Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was given to the participants after randomization. Tumor size, event-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemotherapy | Experimental | Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection. |
|
| control | No Intervention | Patients receive surgical treatment without any neoadjuvant treatments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG regimen | Drug | Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival (EFS) | Event-Free Survival assessed by the investigator according to RECIST 1.1 by investigator, defined as the time from randomization to any of the following events: progression of disease that precludes resection, local or distant recurrence, or death due to any cause, whichever occurs first. | From randomization to any of the following events: progression of disease that precludes resection, local or distant recurrence, or death due to any cause, whichever occurs first. Up to approximately 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival, the time from randomization to death due to any cause | From randomization to death due to any cause. Up to approximately 60 months. |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tingbo Liang, MD PhD | Department of HBP Surgery, SAHZJU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | 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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| D005492 | Folic Acid |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| mFolfirinox | Drug | Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2 |
|
|
The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
| From randomization to the end of neoadjuvant therapy. Up to approximately 60 months. |
| Carbohydrate antigen 19-9 | Serum Carbohydrate antigen 19-9 level | Up to approximately 60 months |
| Serious adverse events incidence | The proportion of patients with grade 3/4 adverse events | Up to approximately 60 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |