Advanced Pancreatic Cancer
Conditions
Keywords
nanoparticle albumin-bound paclitaxel, S-1, advanced pancreatic cancer, objective response rate
Brief summary
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).
Detailed description
Advanced PDA is a lethal disease with a approximately 6 months of median survival. Gemcitabine is always the only approved single agent. The recent results of the phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and overall survival (OS) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. Thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic PDA. S-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. This single-arm study is to explore the efficacy and safety of nab-paclitaxel plus S-1 as first-line treatment in Chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.
Interventions
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Number of cycles: 6 cycles.
DRUGS-1
S-1 is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycles: 6 cycles.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Measure at every 6 weeks (every 2 cycles) | Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to 15 months | Measure of time from study treatment to disease progression or death. |
| Overall survival | up to 2 years | Measure of time from study treatment to patient's death or lost to follow-up. |
| Disease control rate | Measure every 6 weeks (every 2 cycles) | The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST). |
| Safety and tolerability | up to 18 month | Percentage of patients who experience adverse events during this study. |
Countries
China
Outcome results
None listed