Colorectal CancerPhase 2NCT02202928
Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer
A Phase 2 study testing DC-CIK, Radiotherapy and Chemotherapy in people with Colorectal Cancer and Neoplasms, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Neoplasms, Intestinal Neoplasms
- What is being tested?
- DC-CIK, Radiotherapy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2017
- 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
- 18~80 years old;
- Histologically confirmed with colorectal cancer at stage Ⅰ~Ⅲ;
- Patients who can accept curative operations;
- Patients who have a life expectancy of at least 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Who cannot join
- Hemoglobin<8.0 g/dL,Platelet count <75 x 10^9/L; ALT, AST, BUN and Cr 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;
- History of organ allograft;
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- Patients who had distant metastases;
- Patients who had active infection;
- Prior use of any anti-cancer treatment in 30 days;
- Now or recently will join another experimental clinical study ;
- Other situations that the researchers considered unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Jingzhou Central Hospital Immunotherapy center
Jingzhou, Hubei, 434020
About this study
Official title: Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery
The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).
Read the detailed description
60 patients with stageⅠ~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.
- Conditions
- Colorectal Cancer, Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
- Being tested
- DC-CIK, Radiotherapy, Chemotherapy
- Keywords
- Colorectal cancer, DC-CIK, Autologous tumor lysate
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-CIKBiological
8×10^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.
RadiotherapyRadiation
45~50 Gy in 25-28 fractions.
ChemotherapyDrug
Also called FOLFOX
Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chemo-radiotherapy | Sham comparator | After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up. Receives: Radiation: Radiotherapy; Drug: Chemotherapy |
| DC-CIK | Experimental | After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment. Receives: Biological: DC-CIK; Radiation: Radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival
Measured: 3 years
Secondary outcomes (3)
Overall survival
Measured: 3 years
Quality of life (QOL)
Measured: 3 Years
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
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 posted29 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jingzhou Central Hospital
- Responsible party
- Sponsor
- Investigators
- Ke N Zhang, Professor, Principal investigator, Jingzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202928
- Sponsor's protocol ID
- HYK-Colorectal Cancer
- Status last verified
- Jul 2015
- First submitted
- 25 Jul 2014
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery
- ClinicalTrials.gov ID
- NCT02202928
- Acronym / sponsor ID
- HYK-Colorectal Cancer
- Conditions
- Colorectal Cancer, Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
- Keywords
- Colorectal cancer, DC-CIK, Autologous tumor lysate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Collaborators
- Jingzhou Central Hospital
- Study start
- Jul 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jul 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.
The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).
Detailed description
60 patients with stageⅠ~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo-radiotherapy | Sham comparator | Radiation: Radiotherapy, Drug: ChemotherapyAfter accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up. |
| DC-CIK | Experimental | Biological: DC-CIK, Radiation: Radiotherapy, Drug: ChemotherapyAfter accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18~80 years old;
- Histologically confirmed with colorectal cancer at stage Ⅰ~Ⅲ;
- Patients who can accept curative operations;
- Patients who have a life expectancy of at least 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
Key exclusion criteria (11 listed)
- Hemoglobin<8.0 g/dL,Platelet count <75 x 10^9/L; ALT, AST, BUN and Cr 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 |
|---|---|---|
| DC-CIK8×10^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval. | Biological | DC-CIK |
| Radiotherapy45~50 Gy in 25-28 fractions. | Radiation | Chemo-radiotherapy, DC-CIK |
| ChemotherapyAlso: FOLFOXOxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks. | Drug | Chemo-radiotherapy, DC-CIK |
Primary outcome
Progress-free survival
Time frame: 3 years
3 secondary outcomes
Overall survival
Time frame: 3 years
Quality of life (QOL)
Time frame: 3 Years
Phenotypic analysis of T cells
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 28 Dec 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.
Ke N Zhang, Professor principal investigator
Jingzhou Central Hospital
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 DC-CIK, Radiotherapy and Chemotherapy in people with Colorectal Cancer and Neoplasms, run by Shenzhen Hornetcorn Bio-technology Company, LTD 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 5 inclusion and 11 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 28 Dec 2015. 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. Some participants in this study may receive a placebo. 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?
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?
Progress-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 28 Dec 2015.