Autologous Cytokine-induced Killer Cells Combined Chemotherapy In Advanced Pancreatic Cancer

Study Overview

Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer

The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.

Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.

Advanced Cancer

BIOLOGICAL: Cytokine-induced Killer Cells
DRUG: Tegafur-Gimeracil-Oteracil Potassium

HenanCH CIK02

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 2016-12-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-03-31
First Submitted that Met QC Criteria 2016-12-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-04-02
First Posted (ACTUAL) 2016-12-26	Results First Posted N/A	Last Verified 2016-12

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: CIK combined chemotherapy Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.	BIOLOGICAL: Cytokine-induced Killer Cells DRUG: Tegafur-Gimeracil-Oteracil Potassium
ACTIVE_COMPARATOR: Chemotherapy Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w	BIOLOGICAL: Cytokine-induced Killer Cells DRUG: Tegafur-Gimeracil-Oteracil Potassium

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CIK combined chemotherapy

Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.

BIOLOGICAL: Cytokine-induced Killer Cells

DRUG: Tegafur-Gimeracil-Oteracil Potassium

ACTIVE_COMPARATOR: Chemotherapy

Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w

BIOLOGICAL: Cytokine-induced Killer Cells

DRUG: Tegafur-Gimeracil-Oteracil Potassium

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		From the date of randomization to the date of death from any cause up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival		From the date of randomization to the date of first documented progression up to 24 months
Quality of life assessed by Questionnaire		one year by questionnaire

Contacts and Locations

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

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: Quanli Gao, Ph.D., Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

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

Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.
Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.

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Resources

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Clinical Trial Record