Study Of S-1 Plus DC-CIK For Patients With Unresectable Locally Advanced Pancreatic Cancer

Study Overview

Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer

The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic cancer.

N/A

Pancreatic Cancer

BIOLOGICAL: DC-CIK Treatment
DRUG: S1
OTHER: Best supportive care

S1+DC CIK-P

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 2013-01-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-01-16
First Submitted that Met QC Criteria 2013-01-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-01-18
First Posted (ACTUAL) 2013-02-01	Results First Posted N/A	Last Verified 2018-01

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:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: S-1 plus DC-CIK Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repe	BIOLOGICAL: DC-CIK Treatment The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles. DRUG: S1 The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25-<1.5 m2, 50 mg; and >1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is conti
ACTIVE_COMPARATOR: DC-CIK alone DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.	BIOLOGICAL: DC-CIK Treatment The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.
ACTIVE_COMPARATOR: S-1 alone Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repe	DRUG: S1 The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25-<1.5 m2, 50 mg; and >1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is conti
ACTIVE_COMPARATOR: Best supportive care	OTHER: Best supportive care Best supportive care

Primary Outcome Measures	Measure Description	Time Frame
Treatment toxicity	Number of participants with treatment-related adverse events as assessed by CTCAE v3.0	4 years

Secondary Outcome Measures	Measure Description	Time Frame
The disease control rate	the proportion of patients who had a best response rating of complete response, partial response, or stable disease.	4 years
Progression free survival（PFS）	From starting date of enrollment to this study until date of first documented disease progression or date of death from any cause, whichever comes first.	4 years
Overal survival(OS)	From starting date of enrollment to this study until date of death from any cause	4 years
Changing trend of tumor biomarkers	The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy	4 years
Phenotypic analysis of peripheral blood immune cells	Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy	4 years

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:

Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
Capable of oral intake
Between 18 and 80 years old
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Karnofsky Performance Status (KPS) ≥ 70%
Normal functions of heart, lung and bone marrow
Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
Adequate renal function(normal serum creatinine level)
A life expectancy≥ 2 months
Informed consent signed

Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
Any radiotherapy or surgery within the previous 3 weeks
Symptomatic brain metastasis not controlled by corticosteroids
Bone marrow metastasis
Active infection
Serious complications
Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy

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

Jiang N, Qiao G, Wang X, Morse MA, Gwin WR, Zhou L, Song Y, Zhao Y, Chen F, Zhou X, Huang L, Hobeika A, Yi X, Xia X, Guan Y, Song J, Ren J, Lyerly HK. Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined with S-1 in Patients with Advanced Pancreatic Cancer: A Prospective Study. Clin Cancer Res. 2017 Sep 1;23(17):5066-5073. doi: 10.1158/1078-0432.CCR-17-0492. Epub 2017 Jun 13.

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