Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer

Study Overview
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Brief Summary
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This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.

Official Title
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Prospective Phase II Single-arm Study of Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable Pancreatic Cancer

Conditions
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Borderline Resectable Pancreatic Cancer

Intervention / Treatment
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* Drug: nab-paclitaxel and S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have good compliance, can understand the research process of this study, and sign a written informed consent Patients with pathologically confirmed pancreatic adenocarcinoma. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer; Patients with borderline resectable pancreatic cancer ( NCCN Version 1，2019 criteria). ECOG PS 0-1; Tumor size is measurable according to RECIST1.1 criteria Expected survival over 3 months; Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L; Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT; No contraindications to the use of S-1 and nab-paclitaxel. Exclusion Criteria: ≥ Grade 2 existing peripheral neuropathy; 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. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment. 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. Not able to take medicine orally. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study; Participation in other clinical trial within 30 days before the first dose of the drug;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nab-paclitaxel and S-1<br>neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles. | Drug: nab-paclitaxel and S-1<br>* Nab-Paclitaxel: 120 mg/m2 d1, 8, S-1: Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 < 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | proportion of patients who achieved R0 resection | 3 years |