Clinical trial · Interventional
Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
NCT03815461CI-TRIAL-00036735unknownPhase 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 single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .
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
- experiment group
- description
- Nab-paclitaxel+S-1
- interventionNames
- Drug: Nab-paclitaxel and S-1
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 2.5 years
Secondary outcomes (4)
- measure
- R0 resection rate
- timeFrame
- 6 months
- measure
- Overall survival rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patient compliance is good, the research process of this study can be understood, and written informed consent is signed; * Age ≥ 18 years old, ≤ 75 years old; * Histologically or cytologically confirmed pancreatic adenocarcinoma; * no prior treatment; * Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines); * ECOG\<2; * Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L; * Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin \< 1.5 × ULN; * Renal function: serum creatinine is within normal range; * Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment; * Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment; * No contraindication to the use of S-1and albumin-bound paclitaxel. Exclusion Criteria: * Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer); * Interstitial pneumonia or pulmonary fibrosis; * Severe pleural effusion or ascites; * Watery diarrhea; * There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder; * Current or previous patients with grade II peripheral neuropathy; * Abnormal digestive tract or metabolic function, which may affect the s-1 absorber; * Participated in other clinical researchers within 4 weeks prior to enrollment; * Patients who have undergone organ transplantation; * Patients considered by the investigator to be unfit for this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.