Efficacy And Safety Of Paclitaxel Liposome And S-1 As First-line Therapy In Advanced Pancreatic Cancer Patients

Study Overview

Efficacy and Safety of Paclitaxel Liposome and S-1 as First-line Therapy in Advanced Pancreatic Cancer Patients

The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.

Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment

Advanced Pancreatic Cancer

DRUG: Paclitaxel liposome
DRUG: S-1

CSPAC-21

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 2019-12-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-01-01
First Submitted that Met QC Criteria 2020-01-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-01-03
First Posted (ACTUAL) 2020-01-03	Results First Posted N/A	Last Verified 2020-01

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: paclitaxel liposome + S-1 paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w）	DRUG: Paclitaxel liposome Patients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic DRUG: S-1 Patients receive S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a nov

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: paclitaxel liposome + S-1

paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w）

DRUG: Paclitaxel liposome

Patients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic

DRUG: S-1

Patients receive S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a nov

Primary Outcome Measures	Measure Description	Time Frame
Progression free survival	To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.	from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Response Rate	To evaluate the Overall Response Rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.	from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
overall survival	To evaluate the overall survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.	from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Disease control rate	To evaluate the disease control rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.	from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
Quality of life (Qol)	To evaluate the Quality of Life of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.	from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Adverse events	To evaluate the adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.	from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months

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: Xian-Jun Yu, M.D., Ph.D.

Phone Number: +86 21 64175590

Email: yuxianjun@fudanpci.org

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:

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Xian-Jun Yu, M.D., Ph.D., Fudan University

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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