Clinical trial · Interventional
Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer
Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
NCT02124317CI-TRIAL-00025245NAPSPACunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nanoparticle albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nanoparticle albumin-bound paclitaxel, S-1
- description
- nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which 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 cycle: 6 cycles.
- interventionNames
- Drug: nanoparticle albumin-bound paclitaxel
- Drug: S-1
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Measure at every 6 weeks (every 2 cycles)
- description
- Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShi Y, Zhang S, Han Q, Li J, Yan H, Lv Y, Shi H, Liu R, Dai G. Nab-paclitaxel plus S-1 in advanced pancreatic adenocarcinoma (NPSPAC): a single arm, single center, phase II trial. Oncotarget. 2017 Sep 28;8(54):92401-92410. doi: 10.18632/oncotarget.21359. eCollection 2017 Nov 3. PMID 29190925