Pancreatic CancerPhase 1/2NCT01781520
Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
A Phase 1/2 study testing DC-CIK Treatment and S1 in people with Pancreatic Cancer, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- DC-CIK Treatment and S1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2013to 13 Jun 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Cancer Center
Beijing, Beijing Municipality, 100038
About this study
Official title: Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.
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.
- Conditions
- Pancreatic Cancer
- Being tested
- DC-CIK Treatment, S1, Best supportive care
- Keywords
- Pancreatic Cancer, S1, DC-CIK
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-CIK TreatmentBiological
The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.
S1Drug
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.
Best supportive careOther
Best supportive care
| Study group | Role | What they receive |
|---|---|---|
| S-1 plus DC-CIK | Experimental | 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. Receives: Biological: DC-CIK Treatment; Drug: S1 |
| DC-CIK alone | Active comparator | 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. Receives: Biological: DC-CIK Treatment |
| S-1 alone | Active comparator | 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. Receives: Drug: S1 |
| Best supportive care | Active comparator | Not described Receives: Other: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Measured: 4 years
Secondary outcomes (5)
The disease control rate
the proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Measured: 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.
Measured: 4 years
Overal survival(OS)
From starting date of enrollment to this study until date of death from any cause
Measured: 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
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study start1 Jun 2013
- Primary completion30 May 2016
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781520
- Sponsor's protocol ID
- S1+DC CIK-P
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2013
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28611200
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.
- ClinicalTrials.gov ID
- NCT01781520
- Acronym / sponsor ID
- S1+DC CIK-P
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, S1, DC-CIK
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S-1 plus DC-CIK | Experimental | Biological: DC-CIK Treatment, Drug: S1Chemotherapy: 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 alone | Active comparator | Biological: DC-CIK TreatmentDC-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. |
| S-1 alone | Active comparator | Drug: S1Chemotherapy: 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. |
| Best supportive care | Active comparator | Other: Best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC-CIK TreatmentThe DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles. | Biological | DC-CIK alone, S-1 plus DC-CIK |
| S1The 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. | Drug | S-1 alone, S-1 plus DC-CIK |
| Best supportive careBest supportive care | Other | Best supportive care |
Primary outcome
Treatment toxicity
Time frame: 4 years
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
5 secondary outcomes
The disease control rate
Time frame: 4 years
Progression free survival（PFS）
Time frame: 4 years
Overal survival(OS)
Time frame: 4 years
Changing trend of tumor biomarkers
Time frame: 4 years
Phenotypic analysis of peripheral blood immune cells
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Results publication: PubMed 28611200Jiang 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.
- Published article for this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DC-CIK Treatment and S1 in people with Pancreatic Cancer, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment toxicity (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.