Advanced CancerPhase 2NCT03002831
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer
A Phase 2 study testing Cytokine-induced Killer Cells and Tegafur-Gimeracil-Oteracil Potassium in people with Advanced Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Cytokine-induced Killer Cells and Tegafur-Gimeracil-Oteracil Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Oct 2019
- Phase
- Phase 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
- No less than 18 years old
- Karnofsky Performance Status over 60
- Life expectancy more than three months
- Pathological diagnosed as pancreatic epithelial cell carcinoma
- Recurrence after surgery or unresectable
- No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months
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- Measurable lesions (by CT or MRI)
- No serious mental disorders
- Adequate organ and bone marrow functions
- No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation)
- No other malignant tumor history
- Informed consent and willing to participate in this study
Who cannot join
- Received immunosuppressants or glucocorticoid treatment
- Uncontrolled severe infection or unhealed wound caused by suppurative inflammation
- Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months
- Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value
- Other malignant tumor history
- Transaminase>2.5ULN or bilirubin>3ULN or creatinine >1.25ULN
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- Pregnant or lactating women
- Obvious bleeding tendency
- Participated other clinical trails in 1 month
- Other unsuitable conditions: HIV infection, intravenous drug abusers, etc
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study
The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.
Read the detailed description
Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.
- Conditions
- Advanced Cancer
- Being tested
- Cytokine-induced Killer Cells, Tegafur-Gimeracil-Oteracil Potassium
- Keywords
- CIK, Chemotherapy, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-induced Killer CellsBiological
Tegafur-Gimeracil-Oteracil PotassiumDrug
| Study group | Role | What they receive |
|---|---|---|
| CIK combined chemotherapy | Experimental | Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour. Receives: Biological: Cytokine-induced Killer Cells; Drug: Tegafur-Gimeracil-Oteracil Potassium |
| Chemotherapy | Active comparator | Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w Receives: Drug: Tegafur-Gimeracil-Oteracil Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From the date of randomization to the date of death from any cause up to 36 months
Secondary outcomes (2)
Progression Free Survival
Measured: From the date of randomization to the date of first documented progression up to 24 months
Quality of life assessed by Questionnaire
Measured: one year by questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Study halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Quanli Gao, Ph.D., Principal investigator, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002831
- Sponsor's protocol ID
- HenanCH CIK02
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.
PubMed 26741729Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.
PubMed 26842696
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study
- ClinicalTrials.gov ID
- NCT03002831
- Acronym / sponsor ID
- HenanCH CIK02
- Conditions
- Advanced Cancer
- Keywords
- CIK, Chemotherapy, Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Nov 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 26 Dec 2016 (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 determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.
Detailed description
Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIK combined chemotherapy | Experimental | Biological: Cytokine-induced Killer Cells, Drug: Tegafur-Gimeracil-Oteracil PotassiumAutologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour. |
| Chemotherapy | Active comparator | Drug: Tegafur-Gimeracil-Oteracil PotassiumTegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- No less than 18 years old
- Karnofsky Performance Status over 60
- Life expectancy more than three months
- Pathological diagnosed as pancreatic epithelial cell carcinoma
- Recurrence after surgery or unresectable
Key exclusion criteria (10 listed)
- Received immunosuppressants or glucocorticoid treatment
- Uncontrolled severe infection or unhealed wound caused by suppurative inflammation
- Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months
- Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value
- Other malignant tumor history
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 |
|---|---|---|
| Cytokine-induced Killer Cells | Biological | CIK combined chemotherapy |
| Tegafur-Gimeracil-Oteracil Potassium | Drug | CIK combined chemotherapy, Chemotherapy |
Primary outcome
Overall Survival
Time frame: From the date of randomization to the date of death from any cause up to 36 months
2 secondary outcomes
Progression Free Survival
Time frame: From the date of randomization to the date of first documented progression up to 24 months
Quality of life assessed by Questionnaire
Time frame: one year by questionnaire
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Results publication: PubMed 26741729Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.
- Results publication: PubMed 26842696Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.
- Individual participant dataSharing planned: No
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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.
Quanli Gao, Ph.D. principal investigator
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytokine-induced Killer Cells and Tegafur-Gimeracil-Oteracil Potassium in people with Advanced Cancer, run by Henan Cancer Hospital 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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Apr 2020. 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 phase mean?
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 was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
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?
Overall Survival (time frame: From the date of randomization to the date of death from any cause up to 36 months). 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 NCT03002831, which also lists 2 linked publications.
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 2 Apr 2020.