Overview

Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Status:
Completed
Trial end date:
2019-07-11
Target enrollment:
0
Participant gender:
All
Summary
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aiping Zhou
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Tegafur
Criteria
Inclusion Criteria:

- Age, years: 18-75

- Histologically and cytologically confirmed advanced pancreatic cancer , inresectable,
measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy
≥12 weeks;

- Untreated; more than 6 months after the last adjuvant chemotherapy (does not include
taxanes and S1);

- Laboratory examination within 14 days before entering the study should meet following
requirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤
2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤
1.5 x ULN; TBIL ≤ 1.5 x ULN

- Both male and female subjects of potential fertility have to agree effective birth
control during the entire study

- Informed consent

Exclusion Criteria:

- Concurrent other effective treatment (including radiotherapy)

- Resectable patients

- Allergy history to other drugs in the same class patients with pregnancy or lactation

- Known severe internal medical diseases

- Abnormal heart function or relevant history of myocardial infarction and severe
arrhythmia

- Immunocompromised patients, such as HIV positive

- Uncontrollable mental illness

- Other conditions the researchers considered ineligible for the study