Colorectal NeoplasmsPhase 2NCT02487992
The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
A Phase 2 study testing Cytokine-Induced Killer Cells in people with Colorectal Neoplasms, run by The First People's Hospital of Changzhou.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Cytokine-Induced Killer Cells
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2045
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who can accept curative operations 18-70 years old
- Histologically confirmed with colorectal cancer at stage Ⅳ
- Patients who can accept oral drugs;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Who cannot join
- Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Pregnant or lactating patients
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- Patients who are suffering from serious autoimmune disease
- Patients who had used long time or are using immunosuppressant
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- Patients who had active infection
- Patients who are suffering from serious organ dysfunction
- Patients who are suffering from other cancer
- Other situations that the researchers considered unsuitable for this study.
About this study
Official title: The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.
Read the detailed description
1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only S-1 and Bevacizumab (continuous) .
- Conditions
- Colorectal Neoplasms
- Being tested
- Cytokine-Induced Killer Cells
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-Induced Killer CellsBiological
CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.
| Study group | Role | What they receive |
|---|---|---|
| CIK plus S-1 and Bevacizumab | Experimental | Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab.
S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.
Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress. Receives: Biological: Cytokine-Induced Killer Cells |
| S-1 and Bevacizumab | No intervention | S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
Measured: 3 months
Secondary outcomes (1)
Disease-free survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2043 (estimated)
- Study completionJul 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487992
- Sponsor's protocol ID
- CZYY-CRC-001
- Status last verified
- Feb 2016
- First submitted
- 30 Jun 2015
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02487992
- Acronym / sponsor ID
- CZYY-CRC-001
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2043 (estimated)
- Study completion
- Jul 2045 (estimated)
- First posted
- 2 Jul 2015 (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 safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.
Detailed description
1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only S-1 and Bevacizumab (continuous) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIK plus S-1 and Bevacizumab | Experimental | Biological: Cytokine-Induced Killer CellsCytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress. |
| S-1 and Bevacizumab | No intervention | –S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who can accept curative operations 18-70 years old
- Histologically confirmed with colorectal cancer at stage Ⅳ
- Patients who can accept oral drugs;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Key exclusion criteria (10 listed)
- Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Pregnant or lactating patients
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- Patients who are suffering from serious autoimmune disease
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 CellsCIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells. | Biological | CIK plus S-1 and Bevacizumab |
Primary outcome
Overall Survival(OS)
Time frame: 3 months
1 secondary outcome
Disease-free survival
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytokine-Induced Killer Cells in people with Colorectal Neoplasms, run by The First People's Hospital of Changzhou.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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(OS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2016.