Clinical trial · Interventional
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer
NCT02135822CI-TRIAL-00014561NAPGAPunknownPhase 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.
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 |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| nanoparticle albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nanoparticle albumin-bound paclitaxel, gemcitabine
- description
- Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, each 21-day cycle. Number of cycle: 6 cycles.
- interventionNames
- Drug: nanoparticle albumin-bound paclitaxel
- Drug: gemcitabine
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Measure at every 6 weeks (every 2 cycles) up to 18 weeks
- 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
- Progression-free survival
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)
- DERIVEDXu R, Yu X, Hao J, Wang L, Pan H, Han G, Xu J, Zhang Y, Yang S, Chen J, Ying J, Dai G, Li M, Begic D, Lu B, Shen L. Efficacy and safety of weekly nab-paclitaxel plus gemcitabine in Chinese patients with metastatic adenocarcinoma of the pancreas: a phase II study. BMC Cancer. 2017 Dec 22;17(1):885. doi: 10.1186/s12885-017-3887-z. PMID 29273007