We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified February 2017 by Jun Ren MD, PhD, Capital Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781520
First Posted: February 1, 2013
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Other: S-1 plus DC-CIK Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Jun Ren MD, PhD, Capital Medical University:

Primary Outcome Measures:
  • Progression free survival(PFS) [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Two year survival rate [ Time Frame: 2 years ]
  • Adverse events [ Time Frame: 4 years ]
  • Response rate [ Time Frame: 4 years ]
  • Quality of life [ Time Frame: 1 year ]

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, repeated every 3 weeks.

DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis 3 days before administrating S-1 , and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times.

Other: S-1 plus DC-CIK

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781520


Contacts
Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com

Locations
China, Beijing
Capital Medical University Cancer Center Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ren, MD, PhD    86-10-63926317    renjun9688@yahoo.com   
Principal Investigator: Jun Ren, MD,PhD         
Sponsors and Collaborators
Capital Medical University
  More Information

Responsible Party: Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01781520     History of Changes
Other Study ID Numbers: S1+DC CIK-P
First Submitted: January 30, 2013
First Posted: February 1, 2013
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Jun Ren MD, PhD, Capital Medical University:
Pancreatic Cancer
S1
DC-CIK

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases