Nab-paclitaxel Combined With S-1 As Induction Therapy For Locally Advanced Pancreatic Cancer

Study Overview

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

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.

Locally Advanced Pancreatic Cancer

DRUG: Nab-paclitaxel and S-1

CSPC-KAL-PC-05

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-24
First Submitted that Met QC Criteria 2019-01-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-25
First Posted (ACTUAL) 2019-01-24	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: experiment group Nab-paclitaxel+S-1	DRUG: Nab-paclitaxel and S-1 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: experiment group

Nab-paclitaxel+S-1

DRUG: Nab-paclitaxel and S-1

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.

Primary Outcome Measures	Measure Description	Time Frame
PFS		up to 2.5 years

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zhou Aiping

Phone Number: +86 13691161998

Email: zhouap1825@126.com

Study Contact Backup

Name: Zhou Aiping

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Zhou Aiping, National Cancer Center/Cancer Hospital, China

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record