Phase 2 Trial Of Gemcitabine Vs S-1 Vs Gemcitabine Plus Nab-paclitaxel As Adjuvant Chemotherapy Of Post-operative Pancreatic Cancer Patients

Study Overview

Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. the purpose of this study is to three chemotherapy regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with gemcitabine),which is best regimens for raising patients' survival rate, and will provide a chemotherapy choice for clinic therapy of pancreatic cancer.

N/A

Cancer of Pancreas

DRUG: Nab-paclitaxel plus Gemcitabine
DRUG: Gemcitabine monotherapy
DRUG: S-1 monotherapy

XDB-001

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 2017-09-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-09-08
First Submitted that Met QC Criteria 2017-09-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-09-11
First Posted (ACTUAL) 2017-09-11	Results First Posted N/A	Last Verified 2017-09

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:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nab-paclitaxel plus Gemcitabine Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.	DRUG: Nab-paclitaxel plus Gemcitabine Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
EXPERIMENTAL: Gemcitabine monotherapy Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.	DRUG: Gemcitabine monotherapy Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
EXPERIMENTAL: S-1 monotherapy S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.	DRUG: S-1 monotherapy S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nab-paclitaxel plus Gemcitabine

Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

DRUG: Nab-paclitaxel plus Gemcitabine

Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

EXPERIMENTAL: Gemcitabine monotherapy

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

DRUG: Gemcitabine monotherapy

Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

EXPERIMENTAL: S-1 monotherapy

S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

DRUG: S-1 monotherapy

S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

Primary Outcome Measures	Measure Description	Time Frame
Disease free survival(DFS)	To determine the DFS of post-operative patients with pancreatic cancer	3 years
overall survival time (OS)	To determine the OS post-operative patients with pancreatic cancer	5 years
median overall survival time (mOS)	To determine the mOS post-operative patients with pancreatic cancer	5 years

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate(ORR)	All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations	3 years
Quality of Life Assessment		3 years
safety profile	Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups	3 years
Disease control rate(DCR)		3 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: Dabin Xu, M.D.

Phone Number: 8613522065659

Email: xdabin@126.com

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.

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

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