Advanced Pancreatic Cancer Clinical Trial
Official title:
Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study
Verified date | January 2021 |
Source | Chinese Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 11, 2019 |
Est. primary completion date | July 11, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College | Beijing |
Lead Sponsor | Collaborator |
---|---|
Aiping Zhou |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate(ORR) | CR+PR was defined as objective response rate (ORR) | 6 month | |
Secondary | DCR | CR+PR+SD was defined as disease control rate (DCR) | 6 month | |
Secondary | PFS | From date of randomization until date of first documented PD, date of death | 6 month | |
Secondary | OS | From date of randomization until date of death | 1 year | |
Secondary | Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer | Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer | 1 year |
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