Overview

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.