Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Treatment, Prospective, Assignment, Open Label, Single-center, Non-randomized Study An exploratory clinical trial of comparison of Nab-Paclitaxel combined with Gemcitabine and Gemcitabine combined with Tegafur for adjuvant chemotherapy after radical resection of pancreatic cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Tegafur

Criteria

Inclusion Criteria:

• Signed informed content obtained prior to treatment

• Age ≥18 years and ≤ 80 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Pathologically confirmed after R0 resection of pancreatic adenocarcinoma.

• The expected survival after surgery ≥ 6 months

• 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

• Baseline (postoperative) abdominal pelvic CT (plain scan + enhancement) and chest CT scan without tumor lesions;

• No serious adverse events (fatal or life-threatening, persistent or significant loss of function or disability, requiring hospitalization or prolonged hospital stay) within 4-12 weeks after surgery;

• Comply with research visit plans and other program requirements.

Exclusion Criteria:

• with other systemic malignancies

• Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy

• used any other study drug within 5 weeks 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

• Uncontrolled infection, hemorrhage, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination; acute and chronic metabolic acidosis (including ketoacidosis, lactic acidosis) failed to be corrected;

• History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine or tegafur

• Pregnant or nursing women

• Any condition that may compromise patient safety or study data integrity, including serious medical risk factors, medical conditions, and laboratory abnormalities;

• Patients may leave the observation for 7 days or more during the study.