A Phase Ⅲ, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine Versus mFOLFIRINOX in Treating Patients With Borderline Reseactable and Locally Advanced Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
Brief Summary
This is a prospective, single-center, randomized, controlled phase Ⅲ study.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
open-label
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed content obtained prior to treatment
- •Age ≥18 years and ≤ 80 years
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma.
- •No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
- •No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
- •No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards)
- •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
- •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
- •Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN
- •Comply with research visit plans and other program requirements.
Exclusion Criteria
- •with other systemic malignancies
- •Patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy.
- •used any other study drug within 7 days prior to enrollment;
- •Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
- •History of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike.
- •Patients who are using and expected to use warfarin in long term
- •Patients may leave the observation for 14 days or more during the study.
Arms & Interventions
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.
Intervention: Nab paclitaxel plus gemcitabine (Drug)
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.
Intervention: mFOLFIRINOX (Drug)
Outcomes
Primary Outcomes
overall survival
Time Frame: 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 Outcomes
- recurrence free survival(from randomization to recurrence, up to 36 months)
- postoperative complications(up to 36 months)
- objective response rate(up to 36 months)
- resection rate(up to 36 months)
- R0 resection(up to 36 months)
Investigators
Xian-Jun Yu
Vice President of Fudan University Shanghai Cancer Center
Fudan University