nab-paclitaxel combined with s-1 as induction therapy for locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Cancer

Summary: 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 .

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.

Eligibility criteria:
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.