Back to resultsStudy of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC-CIK Treatment
S1
Best supportive care
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, S1, DC-CIK
Eligibility 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
Sites / Locations
- Capital Medical University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
S-1 plus DC-CIK
DC-CIK alone
S-1 alone
Best supportive care
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Treatment toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Secondary Outcome Measures
The disease control rate
the proportion of patients who had a best response rating of complete response, partial response, or stable disease.
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.
Overal survival(OS)
From starting date of enrollment to this study until date of death from any cause
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
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
Full Information
NCT ID
NCT01781520
First Posted
January 30, 2013
Last Updated
January 16, 2018
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01781520
Brief Title
Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
Official Title
Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
June 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, S1, DC-CIK
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-1 plus DC-CIK
Arm Type
Experimental
Arm Description
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.
Arm Title
DC-CIK alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
S-1 alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Best supportive care
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
DC-CIK Treatment
Intervention Description
The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
S1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Best supportive care
Intervention Description
Best supportive care
Primary Outcome Measure Information:
Title
Treatment toxicity
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The disease control rate
Description
the proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Time Frame
4 years
Title
Progression free survival（PFS）
Description
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.
Time Frame
4 years
Title
Overal survival(OS)
Description
From starting date of enrollment to this study until date of death from any cause
Time Frame
4 years
Title
Changing trend of tumor biomarkers
Description
The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy
Time Frame
4 years
Title
Phenotypic analysis of peripheral blood immune cells
Description
Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Capital Medical University Cancer Center
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28611200
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Dendritic+Cell%2FCytokine-Induced+Killer+CellImmunotherapy+Combined+with+S-1+in+Patients+with+Advanced+Pancreatic+Cancer%3AA+Prospective+Study
Description
Published article for this study
Learn more about this trial
Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
We'll reach out to this number within 24 hrs