AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-center, randomized, controlled phase Ⅲ study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Folfirinox; Gemcitabine; Paclitaxel

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.