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

Study Overview
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Brief Summary
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There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.

Official Title
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Phase II Single-arm Trial of Nab-Paclitaxel and S-1 as Neoadjuvant Treatment of Patients With Resectable Pancreatic Cancer

Conditions
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Pancreatic Neoplasms

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: Signed informed-consent form; Treatment-naive PDAC with histological or cytological diagnosis; Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions; Age≥18 years old and ≤70 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; BMI≥18.5 and NRS2002score<3; Expected survival over 3 months; Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN; Exclusion Criteria: Severe Impaired organ functions; Patients who had surgeries, chemotherapy or other treatments before inclusion; Pregnant women or lactating women; Ineligible by the discretion of the investigator.

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 2-4 cycles | Drug: Nab paclitaxel and S-1<br>* Nab-Paclitaxel: 125 mg/m2 d1, 8, during each 3-week cycle. S-1: Body surface area < 1.25 m2, 40 mg bid; Body surface area ≥ 1.25 m2 < 1.50 m2, 50 mg bid; Body surface area ≥1.5 m2, 60 mg bid, d1-14;during each 3-week cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Percentage of patients who achieve partial response (PR) or complete response(CR) based on Response Evaluation Criteria In Solid Tumors (RECIST1.1) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0/R1 resection rate | proportion of patients who achieved R0/R1 resection | 2 years | 
| Disease free survival | The time between operation and the relapse or metastasis of tumors or death | From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months | 
| Overall survival | The time between randomization and death from any cause or lost to follow-up | From date of randomization until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months |