Malignant NeoplasmPhase 3NCT04292769
Clinical Study of DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
A Phase 3 study testing Decitabine and DC-CIK in people with Malignant Neoplasm, run by Li Yu at 1 site in China.
Trial summary
1. Screening stage 2. Evaluation of disease 3. Grouping of patients 4. Infusion of cells 5. Surveillance of adverse effect Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Decitabine and DC-CIK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2020to 20 Jan 2023
- 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 patients aged 18-70 years (including 18 and 70 years);
- Pathological and histological examination confirmed a malignant solid tumor;
- Patients with ECOG score <2, estimated survival time> 3 months.
- Patients with solid tumors have cleared their lesions after treatment, and are unsuitable or unwilling to receive other anti-tumor treatments such as chemotherapy and radiotherapy;
- Patients did not receive any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within 2-4 weeks before enrollment, and their previous treatment-related toxicities have recovered to <1 (hair loss) , Except for low-level toxicity such as peripheral neuritis);
- The patient's venous channel is unobstructed, which can meet the needs of intravenous drip;
- Patients voluntarily participate and sign informed consent, and follow the research treatment plan and visit plan.
Who cannot join
- 1. Patients use large doses of hormones (except for patients using inhaled hormones) within 1 week before enrollment; 2. People with severe autoimmune diseases, immunodeficiency diseases or severe allergies; 3. Patients treated with other cellular immune products (DC, T, NK, and CAR-T, etc.); 4. Patients have uncontrollable infections within 4 weeks before enrollment; 5. Active HBV DNA> 1000copy / mL / Hepatitis C virus (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive; 6. Patients participated in other clinical studies within 6 weeks before enrollment; 7. Patients with mental illness; 8. Patients with a substance abuse / addiction and medical, psychological or social conditions that may interfere with the study or influence the evaluation of the study results; 9. Alcohol dependence in patients; 10. Women who are pregnant (positive urine / blood pregnancy study) or breastfeeding; men or women with a pregnancy plan in the past year; patients cannot guarantee effective contraception during the study period 11. At the discretion of the investigator, the patient has other unsuitable conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen university general hospital
Shenzhen, 518000
LI Yu, Doctor, +8675521839215, liyu301@vip.163.com
About this study
Official title: Clinical Study of Descitabine Enhanced Infusion of Autologous DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
- Screening stage
- Evaluation of disease
- Grouping of patients
- Infusion of cells
- Surveillance of adverse effect
Read the detailed description
- Screening stage：All patients must be confirmed by pathology priorily and reachead remission after surgery or chemo- or radiotherapy. All criteria patients must sign informed consent in advance.
- Evaluation of disease: Systematically assessment of tumor burdern and Physical fitness of all patients.
- Cell preparation：At least one month after the end of the last chemotherapy, 100ml of peripheral blood was collected, and PBMCs were separated and extracted in the tens of thousands and local hundreds of clean laboratories and DC-CIK cells were prepared.
- Baseline assessment: Systematically assess various biochemical indicators. Those who do not meet the infusion criteria will withdraw from the study after being confirmed by researchers.
- Study group: All subjects were randomly divided into test group and control group. The test group was treated with decitabine. The course of treatment was a total of 5 times.
- Infusion：During cell culture and before transfusion, cells should be subjected to strict quality control tests such as bacteria, fungi, mycoplasma, endotoxin, cell activity, DC and T cell identification, etc. The transfusion can be approved only after the quality control is qualified.
- Adverse reaction monitoring: DC-CIK infusion was used to closely observe changes in subjects' blood pressure, body temperature, blood routine, blood biochemistry, electrolytes, coagulation, cytokines and organ functions.
- After the trial is completed, the patient's survival information will be followed up every 3 months by telephone or by visiting the test center.
- Conditions
- Malignant Neoplasm
- Being tested
- Decitabine, DC-CIK
- Keywords
- Decitabine, dendritic cell-cytokine induced killer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Decitabine 10mg / d, intravenous administration d-5 ～ d-1
DC-CIKBiological
Autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109;
| Study group | Role | What they receive |
|---|---|---|
| Decitabine combined with DC-CIK | Experimental | Test group: decitabine combined with autologous DC-CIK cells infusion: decitabine 10mg / d, intravenous administration of d-5 to d-1, autologous DC-CIK cells infusion: first course: d1-d3 The second course: d14-d16; the total number of cells is about 5-10 × 109; IL-2: 200,000 IU / d subcutaneous injection, the first course: d0-d4, the second course: d13-d17, every 2 weeks 1 course of treatment, 2 courses in total. Receives: Drug: Decitabine; Biological: DC-CIK |
| DC-CIK | Active comparator | Control group: autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109; One course: d0-d4, the second course: d13-d17, 1 course every 2 weeks, a total of 2 courses. Receives: Biological: DC-CIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival rate
Measured: up to 2 years
PFS
progression free survival
Measured: up to 2 years
Secondary outcomes (1)
objective response rate
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start21 Jan 2020
- Primary completion20 Jan 2023 (estimated)
- Study completion20 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Yu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292769
- Sponsor's protocol ID
- ONCO-CIK-001
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Descitabine Enhanced Infusion of Autologous DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
- ClinicalTrials.gov ID
- NCT04292769
- Acronym / sponsor ID
- ONCO-CIK-001
- Conditions
- Malignant Neoplasm
- Keywords
- Decitabine, dendritic cell-cytokine induced killer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Li YuUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 20 Jan 2023 (estimated)
- First posted
- 3 Mar 2020 (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.
- Screening stage
- Evaluation of disease
- Grouping of patients
- Infusion of cells
- Surveillance of adverse effect
Detailed description
- Screening stage：All patients must be confirmed by pathology priorily and reachead remission after surgery or chemo- or radiotherapy. All criteria patients must sign informed consent in advance.
- Evaluation of disease: Systematically assessment of tumor burdern and Physical fitness of all patients.
- Cell preparation：At least one month after the end of the last chemotherapy, 100ml of peripheral blood was collected, and PBMCs were separated and extracted in the tens of thousands and local hundreds of clean laboratories and DC-CIK cells were prepared.
- Baseline assessment: Systematically assess various biochemical indicators. Those who do not meet the infusion criteria will withdraw from the study after being confirmed by researchers.
- Study group: All subjects were randomly divided into test group and control group. The test group was treated with decitabine. The course of treatment was a total of 5 times.
- Infusion：During cell culture and before transfusion, cells should be subjected to strict quality control tests such as bacteria, fungi, mycoplasma, endotoxin, cell activity, DC and T cell identification, etc. The transfusion can be approved only after the quality control is qualified.
- Adverse reaction monitoring: DC-CIK infusion was used to closely observe changes in subjects' blood pressure, body temperature, blood routine, blood biochemistry, electrolytes, coagulation, cytokines and organ functions.
- After the trial is completed, the patient's survival information will be followed up every 3 months by telephone or by visiting the test center.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decitabine combined with DC-CIK | Experimental | Drug: Decitabine, Biological: DC-CIKTest group: decitabine combined with autologous DC-CIK cells infusion: decitabine 10mg / d, intravenous administration of d-5 to d-1, autologous DC-CIK cells infusion: first course: d1-d3 The second course: d14-d16; the total number of cells is about 5-10 × 109; IL-2: 200,000 IU / d subcutaneous injection, the first course: d0-d4, the second course: d13-d17, every 2 weeks 1 course of treatment, 2 courses in total. |
| DC-CIK | Active comparator | Biological: DC-CIKControl group: autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109; One course: d0-d4, the second course: d13-d17, 1 course every 2 weeks, a total of 2 courses. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged 18-70 years (including 18 and 70 years);
- Pathological and histological examination confirmed a malignant solid tumor;
- Patients with ECOG score <2, estimated survival time> 3 months.
- Patients with solid tumors have cleared their lesions after treatment, and are unsuitable or unwilling to receive other anti-tumor treatments such as chemotherapy and radiotherapy;
- Patients did not receive any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within 2-4 weeks before enrollment, and their previous treatment-related toxicities have recovered to <1 (hair loss) , Except for low-level toxicity such as peripheral neuritis);
Key exclusion criteria (1 listed)
- 1. Patients use large doses of hormones (except for patients using inhaled hormones) within 1 week before enrollment; 2. People with severe autoimmune diseases, immunodeficiency diseases or severe allergies; 3. Patients treated with other cellular immune products (DC, T, NK, and CAR-T, etc.); 4. Patients have uncontrollable infections within 4 weeks before enrollment; 5. Active HBV DNA> 1000copy / mL / Hepatitis C virus (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive; 6. Patients participated in other clinical studies within 6 weeks before enrollment; 7. Patients with mental illness; 8. Patients with a substance abuse / addiction and medical, psychological or social conditions that may interfere with the study or influence the evaluation of the study results; 9. Alcohol dependence in patients; 10. Women who are pregnant (positive urine / blood pregnancy study) or breastfeeding; men or women with a pregnancy plan in the past year; patients cannot guarantee effective contraception during the study period 11. At the discretion of the investigator, the patient has other unsuitable conditions.
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 |
|---|---|---|
| DecitabineDecitabine 10mg / d, intravenous administration d-5 ～ d-1 | Drug | Decitabine combined with DC-CIK |
| DC-CIKAutologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109; | Biological | DC-CIK, Decitabine combined with DC-CIK |
Primary outcome
OS
Time frame: up to 2 years
overall survival rate
PFS
Time frame: up to 2 years
progression free survival
1 secondary outcome
objective response rate
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: No
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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.
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 Decitabine and DC-CIK in people with Malignant Neoplasm, run by Li Yu 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 7 inclusion and 1 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 3 Mar 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 3 Mar 2020.