Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

Inclusion Criteria:

1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopiccomplete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumorsare excluded.
2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
3. Subject should be able to start treatment no later than 12 weeks postsurgery.
4. ≥18 years of age at the time of signing the informed consent form (ICF).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Acceptable hematology parameters:

• Absolute neutrophil count (ANC) ≥1500 cell/mm^3
• Platelet count ≥100,000/mm^3
• Hemoglobin (Hgb) ≥9 g/dL

7. Acceptable blood chemistry levels:

• Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT)and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
• Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome canhave bilirubin of up to 1.5 x ULN)
• Alkaline phosphatase ≤ 2.5 x ULN
• Serum creatinine within upper limits of normal or calculated clearance ≥50mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be usedfor calculating creatinine clearance (eg, using the Cockroft-Gault formula). Forsubjects with a body mass index (BMI) >30 kg/m2, lean body weight should be usedinstead

8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partialthromboplastin time (PTT) within normal limits (±15%)

Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteriaapply:

1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
2. Presence of or history of metastatic pancreatic adenocarcinoma
3. Any other malignancy within 5 years prior to randomization, with the exception ofadequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skincancer (all treatment of which should have been completed 6 months prior torandomization)
4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemictherapy, defined as ongoing signs/symptoms related to the infection withoutimprovement despite appropriate antibiotics, antiviral therapy, and/or other treatment
5. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressivemedications that would in the opinion of the investigator, increase the risk ofserious neutropenic complications
6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any oftheir excipients
7. Serious medical risk factors involving any of the major organ systems, or seriouspsychiatric disorders, which could compromise the subject's safety or the study dataintegrity. These include, but are not limited to:
8. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
9. History of interstitial lung disease, slowly progressive dyspnea and unproductivecough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonaryhypersensitivity pneumonitis or multiple allergies
10. History of the following within 6 months prior to Cycle 1 Day 1: a myocardialinfarction, severe/unstable angina pectoris, coronary/peripheral artery bypassgraft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolledhypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, orseizure disorder