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This is a prospective, single-center, randomized, controlled phase â…¢ study.
Three hundred patients with borderline resectable and locally advanced pancreatic cancer will be randomized 1:1 (150 :150) to the AG and mFOLFIRINOX chemotherapy groups and to observe the overall survival.
The AG regimen: albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles.
MFOLFIRINOX: Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
After neoadjuvant chemotherapy, the surgery will be evaluated according to the patient's tumor and systemic condition.
The first cycle of adjuvant chemotherapy begins 4-8 weeks after radical resection, and the choice of adjuvant chemotherapy regimen depends on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy maintains the original regimen.Adjuvant chemotherapy has 4 cycles of treatment.
Relevant examinations were performed before and after each cycle of medication to assess safety events, imaging review was performed every 2 cycles during the treatment period and every 3 months during the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albumin bound paclitaxel plus gemcitabine | Experimental | Albumin-bound paclitaxel and gemcitabine were given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles. |
|
| mFOFLIRINOX | Active Comparator | Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab paclitaxel plus gemcitabine | Drug | Albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | To evaluate the overall survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy | from randomization to death, up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence free survival | To evaluate the recurrence free survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy | from randomization to recurrence, up to 36 months |
| objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian-Jun Yu, MD, PhD | Contact | +86 21 64175590 | yuxianjun@fudanpci.org | |
| Wen-Quan Wang, MD, PhD | Contact | +86 21 64175590 | wangwenquan@fudanpci.org |
| Name | Affiliation | Role |
|---|---|---|
| Xian-Jun Yu, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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Three hundred patients with borderline resectable and locally advanced pancreatic cancer are randomized 1:1 to the AG and mFOLFIRINOX chemotherapy groups and to observe the total survival.
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open-label
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|
| mFOLFIRINOX | Drug | Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles. |
|
|
To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy |
| up to 36 months |
| resection rate | The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy. | up to 36 months |
| R0 resection | The proportion of R0 resection among patients who undergo operations. | up to 36 months |
| postoperative complications | The incidence of postoperative complications | up to 36 months |
|
| ID | Term |
|---|---|
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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