AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer
Study Details
Study Description
Brief Summary
This is a prospective, single-center, randomized, controlled phase Ⅲ study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: albumin bound paclitaxel plus gemcitabine 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. |
Drug: Nab paclitaxel plus gemcitabine
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.
Other Names:
|
| Active Comparator: mFOFLIRINOX 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. |
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- overall survival [from randomization to death, up to 36 months]
To evaluate the overall survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
Secondary Outcome Measures
- recurrence free survival [from randomization to recurrence, up to 36 months]
To evaluate the recurrence free survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
- objective response rate [up to 36 months]
To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy
- resection rate [up to 36 months]
The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy.
- R0 resection [up to 36 months]
The proportion of R0 resection among patients who undergo operations.
- postoperative complications [up to 36 months]
The incidence of postoperative complications
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed informed content obtained prior to treatment
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Age ≥18 years and ≤ 80 years
-
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
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Radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma.
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No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
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No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
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No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards)
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White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb)≥ 9 g/dL
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Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
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Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN
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Comply with research visit plans and other program requirements.
Exclusion Criteria:
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with other systemic malignancies
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Patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
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used any other study drug within 7 days prior to enrollment;
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Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
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History of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike.
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Patients who are using and expected to use warfarin in long term
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Patients may leave the observation for 14 days or more during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Xian-Jun Yu, MD, PhD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPAC-28