Stage III Colon CancerPhase 3NCT02280278
Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy
A Phase 3 study testing Radical surgery, Adjuvant chemotherapy and Cytokine-induced killer cell immunotherapy in people with Stage III Colon Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage III Colon Cancer
- What is being tested?
- Radical surgery, Adjuvant chemotherapy and Cytokine-induced killer cell immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2019
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
- Stage III colon cancer
- undergone complete resection of primary tumor
- Completed standard adjuvant chemotherapy
- within 120 days of completion of standard therapy
- ECOG performancer status 0-2
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- Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
- ANC ≥ 1.0 x 109/L
- Platelets ≥ 100 x 109/L
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 2.0 x the upper limit normal
- AST \& ALT ≤ 5 x the upper limit normal
- Completed the following investigations
- Completed the following investigations
Who cannot join
- HIV positive or other Immunodeficiency disease
- recently use of high dose glucocorticoid
- Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg)
- History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
- Patient having known allergy to capecitabine or Oxaliplatin
- Pregnant, lactating
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guagzhou, Guangdong, 510060
Rong-Xin Zhang, Doc., +86 20 87343456, zhangrx@sysucc.org.cn
Xiao-Shi Zhang, Doc., +86 20 87343456, zhangxs@sysucc.org.cn
About this study
Official title: The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.
- Conditions
- Stage III Colon Cancer
- Being tested
- Radical surgery, Adjuvant chemotherapy, Cytokine-induced killer cell immunotherapy
- Keywords
- colon cancer, cytokine-induced killer cell immunotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical surgeryProcedure or surgery
Adjuvant chemotherapyDrug
Cytokine-induced killer cell immunotherapyBiological
| Study group | Role | What they receive |
|---|---|---|
| CIK group | Experimental | Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group. Receives: Procedure: Radical surgery; Drug: Adjuvant chemotherapy; Biological: Cytokine-induced killer cell immunotherapy |
| Control group | Active comparator | Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy. Receives: Procedure: Radical surgery; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 3 years
Secondary outcomes (2)
survival rate
Measured: 5 years
toxin-side effect
Toxin-side effect will be assessed by laboratory test, clinicians and questionary
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colon CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Wu, Sun Yat-sen University
- Investigators
- Xiao-Jun Wu, Prof., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280278
- Sponsor's protocol ID
- 5010010
- Status last verified
- Nov 2014
- First submitted
- 29 Oct 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
- ClinicalTrials.gov ID
- NCT02280278
- Acronym / sponsor ID
- 5010010
- Conditions
- Stage III Colon Cancer
- Keywords
- colon cancer, cytokine-induced killer cell immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (estimated)
- First posted
- 31 Oct 2014 (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.
We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIK group | Experimental | Procedure: Radical surgery, Drug: Adjuvant chemotherapy, Biological: Cytokine-induced killer cell immunotherapyStage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group. |
| Control group | Active comparator | Procedure: Radical surgery, Drug: Adjuvant chemotherapyStage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
- Stage III colon cancer
- undergone complete resection of primary tumor
- Completed standard adjuvant chemotherapy
- within 120 days of completion of standard therapy
Key exclusion criteria (6 listed)
- HIV positive or other Immunodeficiency disease
- recently use of high dose glucocorticoid
- Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg)
- History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
- Patient having known allergy to capecitabine or Oxaliplatin
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 |
|---|---|---|
| Radical surgery | Procedure or surgery | CIK group, Control group |
| Adjuvant chemotherapy | Drug | CIK group, Control group |
| Cytokine-induced killer cell immunotherapy | Biological | CIK group |
Primary outcome
Disease free survival
Time frame: 3 years
2 secondary outcomes
survival rate
Time frame: 5 years
toxin-side effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
Xiao-Jun Wu, Prof. principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radical surgery, Adjuvant chemotherapy and Cytokine-induced killer cell immunotherapy in people with Stage III Colon Cancer, run by Sun Yat-sen 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 14 inclusion and 6 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 5 Nov 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiao-Jun Wu, Prof. (+86 20 87343456, wuxj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 3 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 5 Nov 2014.