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

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ClinicalTrials.gov Identifier: NCT01781520
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Biological: DC-CIK Treatment Drug: S1 Other: Best supportive care Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : May 30, 2016
Actual Study Completion Date : June 13, 2017

Resource links provided by the National Library of Medicine


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, repeated every 3 weeks.

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.

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 continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.

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, repeated every 3 weeks.
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 continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.

Active Comparator: Best supportive care Other: Best supportive care
Best supportive care




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


Secondary Outcome Measures :
  1. The disease control rate [ Time Frame: 4 years ]
    the proportion of patients who had a best response rating of complete response, partial response, or stable disease.

  2. Progression free survival(PFS) [ Time Frame: 4 years ]
    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.

  3. Overal survival(OS) [ Time Frame: 4 years ]
    From starting date of enrollment to this study until date of death from any cause

  4. Changing trend of tumor biomarkers [ Time Frame: 4 years ]
    The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy

  5. Phenotypic analysis of peripheral blood immune cells [ Time Frame: 4 years ]
    Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
China, Beijing
Capital Medical University Cancer Center
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Capital Medical University

Additional Information:
Publications of Results:
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 Posted: February 1, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

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