Clinical trial NCT04617821: AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Borderline Resectable Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma
Keywords: neoadjuvant chemotherapy
albumin bound paclitaxel
mFOLFIRINOX
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: from randomization to death, up to 36 months
Secondary outcomes:
measure: recurrence free survival
timeFrame: from randomization to recurrence, up to 36 months
measure: objective response rate
timeFrame: up to 36 months
measure: resection rate
timeFrame: up to 36 months
measure: R0 resection
timeFrame: up to 36 months
measure: postoperative complications
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xian-Jun Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: