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

• Status: Not yet recruiting
• Trial end date: 2023-10-02
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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.