Colonic NeoplasmsPhase 2CIKCCNCT01929499
Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
A Phase 2 study testing cytokine-induced killer cells in people with Colonic Neoplasms, run by Yanjuan Zhu at 1 site in China.
Trial summary
It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- cytokine-induced killer cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colon cancer in stage III or stage II with high risk after R0 resection
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
- Life expectancy of at least 3 months;
- Normal bone marrow, liver, renal, heart and lung function;
- Age between 18-80;
- Patients who provided written informed consent for this study
Who cannot join
- With uncontrolled other malignant tumors;
- With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
- Patients who need to treat with radiotherapy;
- Patients who accepted other immunotherapy
- With sever mental disease or disease with central nervous system (CNS);
- With the history of organ transplantation, including bone marrow transplantation or stem cell transplantation;
- Patients with auto immune diseases;
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Yanjuan Zhu, (+86)13902260217, zyjsophy@hotmail.com
Haibo Zhang, (+86)13724123615, haibozh@aliyun.com
About this study
Official title: Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.
The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).
- Conditions
- Colonic Neoplasms
- Being tested
- cytokine-induced killer cells
- Keywords
- Colon cancer, Cytokine-induced killer cells, Adjuvant immunotherapy, Adjuvant chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine-induced killer cellsBiological
Also called CIK, cytokine induced killer cells
| Study group | Role | What they receive |
|---|---|---|
| synchronous CIK group | Experimental | After colectomy, patients will accept chemotherapy combined with cytokine-induced killer cells (CIK) therapy synchronously for 6 months.
For CapeOx regimen:
3×109 CIK cells on days 1-3; Oxaliplatin 130mg/m2 on day 7; Capecitabine 1000mg/m2 twice daily on days 7-20; Repeat every 3 weeks for 6-8 cycles.
For mFolfox6 regimen:
Oxaliplatin 85mg/m2 IV over 2 hours on day 1; Leucovorin 400mg/m2 IV over 2 hours on day 1; 5-FU 400mg/m2 IV bolus on day 1, then 2400mg/m2 IV continuous infusion over 46-48 hous; 3×109 CIK cells on days 9-11; Oxaliplatin 85mg/m2 IV over 2 hours on day 15; Leucovorin 400mg/m2 IV over 2 hours on day 15; 5-fluorouracil (5-FU) 400mg/m2 IV bolus on day 15, then 2400mg/m2 IV continuous infusion over 46-48 hours; Repeat every 4 weeks for 5-6 cycles. Receives: Biological: cytokine-induced killer cells |
| sequence CIK group | Experimental | After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens(the same as those in arm A), followed by 6-8 cycles of cytokine-induced killer cells (CIK) therapy at least 2 weeks later. Receives: Biological: cytokine-induced killer cells |
| control group | No intervention | After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens （the same as those in arm A）. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS (Disease free survival)
Patients who were recurrence free at the end of study or lost to follow-up were censored
Measured: Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years.
Secondary outcomes (4)
OS (overall survival)
Patients who were survival at the end of study or lost to follow-up were censored
Measured: Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years.
Side effect
Any undesirable secondary effect which occurs in addition to the desired therapeutic effect of CIK or chemotherapy, during the period from the first cycle of chemotherapy or CIK infusion to the end of study. The side effects were described according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events)
Measured: Up to 2 years
T lymphocyte subset
During the period of CIK infusion
Measured: Up to 6 months
QoL (quality of life)
During the period of chemotherapy and CIK infusion
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanjuan Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanjuan Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Haibo Zhang, MD, Principal investigator, Guangdong Provincial Hospital of Chinese Medicine, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929499
- Sponsor's protocol ID
- CIKCC
- Acronym
- CIKCC
- Status last verified
- Aug 2013
- First submitted
- 20 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
- ClinicalTrials.gov ID
- NCT01929499
- Acronym / sponsor ID
- CIKCC / CIKCC
- Conditions
- Colonic Neoplasms
- Keywords
- Colon cancer, Cytokine-induced killer cells, Adjuvant immunotherapy, Adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Yanjuan ZhuUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 28 Aug 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.
It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.
The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| synchronous CIK group | Experimental | Biological: cytokine-induced killer cellsAfter colectomy, patients will accept chemotherapy combined with cytokine-induced killer cells (CIK) therapy synchronously for 6 months. For CapeOx regimen: 3×109 CIK cells on days 1-3; Oxaliplatin 130mg/m2 on day 7; Capecitabine 1000mg/m2 twice daily on days 7-20; Repeat every 3 weeks for 6-8 cycles. For mFolfox6 regimen: Oxaliplatin 85mg/m2 IV over 2 hours on day 1; Leucovorin 400mg/m2 IV over 2 hours on day 1; 5-FU 400mg/m2 IV bolus on day 1, then 2400mg/m2 IV continuous infusion over 46-48 hous; 3×109 CIK cells on days 9-11; Oxaliplatin 85mg/m2 IV over 2 hours on day 15; Leucovorin 400mg/m2 IV over 2 hours on day 15; 5-fluorouracil (5-FU) 400mg/m2 IV bolus on day 15, then 2400mg/m2 IV continuous infusion over 46-48 hours; Repeat every 4 weeks for 5-6 cycles. |
| sequence CIK group | Experimental | Biological: cytokine-induced killer cellsAfter colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens(the same as those in arm A), followed by 6-8 cycles of cytokine-induced killer cells (CIK) therapy at least 2 weeks later. |
| control group | No intervention | –After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens （the same as those in arm A）. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Colon cancer in stage III or stage II with high risk after R0 resection
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
- Life expectancy of at least 3 months;
- Normal bone marrow, liver, renal, heart and lung function;
- Age between 18-80;
Key exclusion criteria (8 listed)
- With uncontrolled other malignant tumors;
- With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
- Patients who need to treat with radiotherapy;
- Patients who accepted other immunotherapy
- With sever mental disease or disease with central nervous system (CNS);
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 cellsAlso: CIK, cytokine induced killer cells | Biological | sequence CIK group, synchronous CIK group |
Primary outcome
DFS (Disease free survival)
Time frame: Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years.
Patients who were recurrence free at the end of study or lost to follow-up were censored
4 secondary outcomes
OS (overall survival)
Time frame: Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years.
Side effect
Time frame: Up to 2 years
T lymphocyte subset
Time frame: Up to 6 months
QoL (quality of life)
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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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.
Haibo Zhang, MD principal investigator
Guangdong Provincial Hospital of Chinese Medicine, China
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 in people with Colonic Neoplasms, run by Yanjuan Zhu 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 6 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: status not confirmed, as of the sponsor's last update on 29 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanjuan Zhu ((+86)13902260217, zyjsophy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (Disease free survival) (time frame: Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years.). 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 29 Aug 2013.