Advanced Pancreatic Cancer Clinical Trial
— NAPSPACOfficial title:
Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
Verified date | December 2016 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | May 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Signed informed-consent form. 2. Age no less than 18 years. 3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions. 4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks. 5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. 6. Adequate liver/bone marrow function. 7. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end. 8. Compliant, and can be followed up regularly. Exclusion Criteria: 1. Pregnant or breast-feeding female, or not willing to take contraception measures during study. 2. Serious infection requiring antibiotics intervention during recruitment. 3. Allergic to study drug. 4. More than grade 1 neuropathy. 5. Uncontrolled brain metastasis or mental illness. 6. Congestive heart failure, uncontrolled cardiac arrhythmia, etc. 7. Other malignancy within 5 years. 8. Can't be followed up or obey protocol. 9. Ineligible by the discretion of the investigator. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST). | Measure at every 6 weeks (every 2 cycles) | No |
Secondary | Progression-free survival | Measure of time from study treatment to disease progression or death. | up to 15 months | No |
Secondary | Overall survival | Measure of time from study treatment to patient's death or lost to follow-up. | up to 2 years | No |
Secondary | Disease control rate | The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST). | Measure every 6 weeks (every 2 cycles) | No |
Secondary | Safety and tolerability | Percentage of patients who experience adverse events during this study. | up to 18 month | Yes |
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