Clinical trial · Interventional
Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer
Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer
NCT03636308CI-TRIAL-00034407ASAGPACunknownPhase 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)
This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| nanoparticle albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| S1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AS:Nanoparticle albumin-bound paclitaxel,S-1
- description
- Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle. S-1 is orally administered (BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
- interventionNames
- Drug: nanoparticle albumin-bound paclitaxel
- Drug: S1
- type
- ACTIVE_COMPARATOR
- label
- AG:Nanoparticle albumin-bound paclitaxel,Gemcitabine
- description
- Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
- interventionNames
- Drug: nanoparticle albumin-bound paclitaxel
- Drug: Gemcitabine
Primary outcomes (1)
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 locally advanced or metastatic disease. 6. At least 4 weeks since completion of the last operation except for diagnostic biopsy. 7. At least 4 weeks since completion of radiotherapy to lesions. 8. Not suitable for local treatment. 9. Adequate liver/bone marrow function. 10. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end. 11. Compliant, and can be followed up regularly. Exclusion Criteria: 1. Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease. 2. Pregnant or breast-feeding female, or not willing to take contraception measures during study. 3. Serious infection requiring antibiotics intervention during recruitment. 4. Allergic to study drug. 5. More than grade 1 neuropathy. 6. Uncontrolled brain metastasis or mental illness. 7. Congestive heart failure, uncontrolled cardiac arrhythmia, etc. 8. Other malignancy within 5 years. 9. Can't be followed up or obey protocol. 10. Ineligible by the discretion of the investigator.
References
Publications (2)
- DERIVEDJin M, Liu HL, Xue J, Ma H, Liu JL, Lin ZY, Wang J, Bao LQ, Luo ZG, Yu XJ, Li S, Hu JL, Zhang T. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer: a multicenter, randomized, phase II study. Oncologist. 2024 Oct 3;29(10):e1406-e1418. doi: 10.1093/oncolo/oyae171. PMID 38990195
- DERIVEDZong Y, Yuan J, Peng Z, Lu M, Wang X, Shen L, Zhou J. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. J Cancer Res Clin Oncol. 2021 May;147(5):1529-1536. doi: 10.1007/s00432-020-03442-0. Epub 2020 Nov 15. PMID 33191450