Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- PFS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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);
- •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.
Arms & Interventions
experiment group
Nab-paclitaxel+S-1
Intervention: Nab-paclitaxel and S-1 (Drug)
Outcomes
Primary Outcomes
PFS
Time Frame: up to 2.5 years
Secondary Outcomes
- 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)
Investigators
Aiping Zhou
Cancer Hospital & Institute
Chinese Academy of Medical Sciences