Status:
UNKNOWN
Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Locally Advanced Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03815461
Start Date
February 1 2019
End Date
October 2 2023
Last Update
January 25 2019
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China