Gemcitabine, Nab-paclitaxel, Pancreatic Cancer, S1
Conditions
Keywords
pancreatic cancer, nab-paclitaxel, gemcitabine, S1
Brief summary
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
Detailed description
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.
Interventions
DRUGS1 or Gemcitabine
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological or cytological confirmation of pancreatic adenocarcinoma * Distant metastatic or unresctable locally advanced diseases * CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment * At least one lesion measurable by RECIST v1.1 criteria * Life expectancy\> 3 months * No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion) * No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone) * Pain must be monitored before inclusion * 18 years \< age \< 70 * Performance status: 0-1 * ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL * ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found * Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), * creatinine \< 120 μmol/L, or MDRD creatinine clearance \> 60 mL/min * Patient information and signature of 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 6 month | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1 year | overall survival |
| ORR | 6 month | objective response rate |
| DCR | 6 month | CR+PR+SD was defined as disease control rate (DCR) |
| Safety profile :Adverse events of nab-Paclitaxel plus S-1 | 1 year | Adverse events of nab-Paclitaxel plus S-1 |
Countries
China
Contacts
Primary ContactZhenyu lin, MD
Backup ContactTao Zhang, MD
Outcome results
None listed