Clinical trial · Interventional
Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer
Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
- 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 study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.
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 |
|---|---|---|---|
| Locally Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-paclitaxel and S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel and S-1
- description
- chemotherapy of Nab-Paclitaxel and S-1, repeat 21 days for up to 8 cycles. The following treatment including pancreatectomy, continuing same chemotherapy, S-1 maintenance therapy, or radiotherapy will be decided after discussion between physicians and patients.
- interventionNames
- Drug: Nab-paclitaxel and S-1
Primary outcomes (1)
- measure
- 6-month progression-free survival (PFS)
- timeFrame
- 6 months
- description
- The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.
Secondary outcomes (1)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients have good compliance, can understand the research process of this study, and sign a written informed consent 2. Patients with pathologically confirmed pancreatic adenocarcinoma. 3. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer; 4. Patients with locally advanced pancreatic cancer ( NCCN Version 1,2019 criteria). 5. ECOG PS 0-1; 6. Tumor size is measurable according to RECIST1.1 criteria 7. Expected survival over 3 months; 8. Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L; 9. Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT; 10. No contraindications to the use of S-1 and nab-paclitaxel. Exclusion Criteria: 1. ≥ Grade 2 existing peripheral neuropathy; 2. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer. 3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment. 4. Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization. 5. Not able to take medicine orally. 6. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study; 7. Participation in other clinical trial within 30 days before the first dose of the drug;
References
Publications (1)
- DERIVEDCao Z, Qiu J, Luo W, Li J, Chen H, Liu Y, Li S, Li F, Yang Y, Cheng Y, Zhang T, Xue H, Bai C, Zhao Y. Nab-paclitaxel plus S-1 induction chemotherapy for patients with locally advanced pancreatic cancer: a multicenter, open-label phase 2 study. Signal Transduct Target Ther. 2026 Jun 22;11(1):243. doi: 10.1038/s41392-026-02741-1. PMID 42324245