Colorectal CancerPhase 2/3NCT02415699
DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
A Phase 2/3 study testing Fluorouracil, Oxaliplatin and Leucovorin in people with Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fluorouracil, Oxaliplatin and Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 2020
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III colon cancer
- Undergone complete resection of primary tumor
- Completed standard adjuvant chemotherapy
- ECOG performancer status 0-2
- Adequate hematologic, hepatic and renal functions
Who cannot join
- HIV positive or other Immunodeficiency disease
- Uncontrolled hypertension
- History of recent cancers in the past 5 years
- Patients with previous or concurrent malignancy or any anti-cancer therapy
- Patients who were allergic to platinum drugs or fluorouracil
- Pregnant patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.
- Conditions
- Colorectal Cancer
- Being tested
- Fluorouracil, Oxaliplatin, Leucovorin, DC-CIK
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Also called 5-FU
OxaliplatinDrug
LeucovorinDrug
DC-CIKBiological
| Study group | Role | What they receive |
|---|---|---|
| DC-CIK Immunotherapy Plus Chemotherapy | Experimental | Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group Receives: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Biological: DC-CIK |
| Chemotherapy Alone | Active comparator | Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone. Receives: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 2 years
Secondary outcomes (2)
Overall survival
Measured: 2 years
Side Effect
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2020 (estimated)
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.
- More trials run by Sixth Affiliated Hospital, 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415699
- Sponsor's protocol ID
- 2015045010
- Status last verified
- Apr 2015
- First submitted
- 9 Apr 2015
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT02415699
- Acronym / sponsor ID
- 2015045010
- Conditions
- Colorectal Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 14 Apr 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.
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DC-CIK Immunotherapy Plus Chemotherapy | Experimental | Drug: Fluorouracil, Drug: Oxaliplatin, Drug: Leucovorin, Biological: DC-CIKStage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group |
| Chemotherapy Alone | Active comparator | Drug: Fluorouracil, Drug: Oxaliplatin, Drug: LeucovorinStage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stage III colon cancer
- Undergone complete resection of primary tumor
- Completed standard adjuvant chemotherapy
- ECOG performancer status 0-2
- Adequate hematologic, hepatic and renal functions
Key exclusion criteria (6 listed)
- HIV positive or other Immunodeficiency disease
- Uncontrolled hypertension
- History of recent cancers in the past 5 years
- Patients with previous or concurrent malignancy or any anti-cancer therapy
- Patients who were allergic to platinum drugs or fluorouracil
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 |
|---|---|---|
| FluorouracilAlso: 5-FU | Drug | Chemotherapy Alone, DC-CIK Immunotherapy Plus Chemotherapy |
| Oxaliplatin | Drug | Chemotherapy Alone, DC-CIK Immunotherapy Plus Chemotherapy |
| Leucovorin | Drug | Chemotherapy Alone, DC-CIK Immunotherapy Plus Chemotherapy |
| DC-CIK | Biological | DC-CIK Immunotherapy Plus Chemotherapy |
Primary outcome
Disease free survival
Time frame: 2 years
2 secondary outcomes
Overall survival
Time frame: 2 years
Side Effect
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fluorouracil, Oxaliplatin and Leucovorin in people with Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 5 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 14 Apr 2015. 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 combined 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.
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 Xiaojian Wu, MD, PHD (020-38254009, sumswxj@126.com), 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: 2 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 14 Apr 2015.