Colorectal CancerPhase 4NCT03084809
Chemotherapy Combined With CIK Treating Colon Cancer
A Phase 4 study testing Cytokine-induced killer cells+ FOLFOX4 and FOLFOX4 in people with Colorectal Cancer and Cytokine-induced Killer Cells, run by China Meitan General Hospital.
Trial summary
Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Colorectal Cancer, Cytokine-induced Killer Cells, Postoperative Complications
- What is being tested?
- Cytokine-induced killer cells+ FOLFOX4 and FOLFOX4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2012to 15 Sep 2014
- Phase
- Phase 4
- 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 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor, Nodes, Metastasis (TNM) stage of II or III;
- Patients received radical resection of colon cancer;
- Pathological diagnosis of adenocarcinoma;
- Patients not received radiotherapy and chemotherapy before surgery;
- The preoperative examination confirmed without systemic metastasis;
- Patient has the Karnofsky score more than 70 points;
- Subjects signed informed consent.
Who cannot join
- Patients who was serious allergy to any of the ingredients of drugs used in this study;
- Patients who unable to comply with the treatment plan or research program;
- Patients with severe systemic disease that the researchers judged will be unable to complete the study;
- Patients have severe heart disease, such as myocardial infarction within 6 months;
- Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
- Patients received radiotherapy;
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- Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
- Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
- Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
- Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
- Patients with serious active infections;
- Woman who are pregnant or lactating.
About this study
Official title: Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Read the detailed description
Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
- Being tested
- Cytokine-induced killer cells+ FOLFOX4, FOLFOX4
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-induced killer cells+ FOLFOX4Drug
Also called CIK + Oxaliplatin + leucovorin + 5-FU
Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
FOLFOX4Drug
Also called Oxaliplatin + leucovorin + 5-FU
Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cytokine-induced killer cells + FOLFOX4 | Experimental | Cytokine-induced killer cells + FOLFOX4 intervention:
Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks.
Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days. Receives: Drug: Cytokine-induced killer cells+ FOLFOX4 |
| FOLFOX4 | Experimental | FOLFOX4 intervention:
Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Receives: Drug: FOLFOX4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival in 2 years
Measured: 2 years (24 months)
Secondary outcomes (2)
Relapse Free Survival in 3 years
Measured: Follow-up: 3 years
5 year Overall Survival
Measured: Follow-up: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start6 May 2012
- Primary completion15 Sep 2014
- Study completion15 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin \[FOLFOX4\]) combined with cytokine-induced killer cells (CIK) Group 2: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin \[FOLFOX4\])
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Meitan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Peng, China Meitan General Hospital
- Investigators
- Li-Min Wang, Dr., Principal investigator, Center for Drug Evaluation, China food and Drug Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084809
- Sponsor's protocol ID
- CIK-2
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: whether individual participant data (IPD) could be shared must obtain the consent of the subjects
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT03084809
- Acronym / sponsor ID
- CIK-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- China Meitan General HospitalUniversity, hospital or other
- Study start
- 6 May 2012 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 15 Sep 2014 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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.
Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Detailed description
Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4]) combined with cytokine-induced killer cells (CIK) Group 2: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4])
| Arm | Type | Receives |
|---|---|---|
| Cytokine-induced killer cells + FOLFOX4 | Experimental | Drug: Cytokine-induced killer cells+ FOLFOX4Cytokine-induced killer cells + FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks. Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days. |
| FOLFOX4 | Experimental | Drug: FOLFOX4FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Tumor, Nodes, Metastasis (TNM) stage of II or III;
- Patients received radical resection of colon cancer;
- Pathological diagnosis of adenocarcinoma;
- Patients not received radiotherapy and chemotherapy before surgery;
- The preoperative examination confirmed without systemic metastasis;
Key exclusion criteria (12 listed)
- Patients who was serious allergy to any of the ingredients of drugs used in this study;
- Patients who unable to comply with the treatment plan or research program;
- Patients with severe systemic disease that the researchers judged will be unable to complete the study;
- Patients have severe heart disease, such as myocardial infarction within 6 months;
- Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
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+ FOLFOX4Also: CIK + Oxaliplatin + leucovorin + 5-FUDay 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days. | Drug | Cytokine-induced killer cells + FOLFOX4 |
| FOLFOX4Also: Oxaliplatin + leucovorin + 5-FUDay 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. | Drug | FOLFOX4 |
Primary outcome
Relapse Free Survival in 2 years
Time frame: 2 years (24 months)
2 secondary outcomes
Relapse Free Survival in 3 years
Time frame: Follow-up: 3 years
5 year Overall Survival
Time frame: Follow-up: 5 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 21 Mar 2017.
- Individual participant dataSharing planned: Undecided. whether individual participant data (IPD) could be shared must obtain the consent of the subjects
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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.
Li-Min Wang, Dr. principal investigator
Center for Drug Evaluation, China food and Drug Administration
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytokine-induced killer cells+ FOLFOX4 and FOLFOX4 in people with Colorectal Cancer and Cytokine-induced Killer Cells, run by China Meitan General Hospital.
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 7 inclusion and 12 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 21 Mar 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Relapse Free Survival in 2 years (time frame: 2 years (24 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 21 Mar 2017.