Spots Global Cancer Trial Database for Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

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Trial Identification

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

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

Study ID: NCT03815461

Conditions

Locally Advanced Pancreatic Cancer

Interventions

Nab-paclitaxel and S-1

Study Description

Brief 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 .

Detailed Description: 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.