Overview

Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the activity and safety of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Albumin-Bound Paclitaxel
Fluorouracil
Folic Acid
Gemcitabine
Leucovorin
Levoleucovorin
Oxaliplatin
Paclitaxel
Criteria
Inclusion Criteria:

- Signed informed content obtained prior to treatment

- Age ≥ 18 years and ≤ 75 years

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

- Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed
pathology if adenocarcinoma is predominant) after R0 or R1 resection. The pathological
staging does not exceed the stage ⅡB. And the patients have received gemcitabine as
adjuvant chemotherapy after curative resection.

- There is progression or recurrence of tumor during the course of adjuvant chemotherapy
with gemcitabine, or within 6 months after the whole courses of treatment.

- No severe defects in hematological system, immune system, cardiac function and
pulmonary function.

- White blood cell (WBC) ≥ 4 × 10^9/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
Platelets (PLT) ≥ 100 × 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL

- Aspartate aminotransferase (AST) (serum glutamate oxaloacetate transaminase (SGOT))/
alanine aminotransferase (ALT) (serum glutamate 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

- The patients are willing to comply to the study plan and other requirements.

Exclusion Criteria:

- There is another malignant tumor with the patient.

- Patients who have received any form of anti-tumor therapy within 4 weeks prior to the
enrollment, including chemotherapy, radiotherapy, interventional chemoembolization,
radiofrequency ablation, and molecular targeted therapy

- Use of any other investigational agents within 4 weeks prior to the enrollment.

- The progression or recurrence of tumor occurs after 6 months of the course of the
adjuvant chemotherapy with gemcitabine.

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, internal hemorrhage, pancreatic leakage, bile leakage,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study
requirements.

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to the drugs.

- Metabolic acidosis, acute or chronic, including ketoacidosis

- Pregnant or nursing women

- Any event or condition that is possible to harm the safety of the patients or the
integrities of data, including severe medical risk factors, medical conditions, and
laboratory disorders.

- Patients who are unwilling or unable to comply with study procedures, or may be absent
from the observation for more than 7 days.