Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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 .

Detailed Description
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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 . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles. During the study, if the subject's weight change was ≤10% from baseline, the dose was calculated based on the measured value at baseline. If the change was >10%, the body surface area of the subject should be recalculated and the dose administered should be adjusted. . Study treatment period Borderline resectable: According to the results of imaging examination, MDT discussed to determine the surgical resectability and timing of surgery. The chemotherapy time was 4-6 cycles. Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging examination, MDT determined the resectability of the operation. It was decided by the investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or radiotherapy.

Official Title
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Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

Conditions
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Locally Advanced 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: experiment group<br>Nab-paclitaxel+S-1 | Drug: Nab-paclitaxel and S-1<br>* Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | up to 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate |  | 6 months | 
| Overall survival rate |  | 2 years | 
| Overall survival |  | up to 2.5 years | 
| Adverse reaction rate |  | up to 2.5 years |