Precision CellsPhase 1/2NCT02862613
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
A Phase 1/2 study testing TACE and Precision Cells in people with Precision Cells and Transcatheter Arterial Chemoembolization, run by Shanghai International Medical Center at 1 site in China.
Trial summary
Objectives: To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer
- What is being tested?
- TACE and Precision Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2018
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~65 years old, male or female;
- Life expectancy≥6 months;
- ECOG score: 0-3;
- Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
- Enough venous channel, no other contraindications to the separation and collection of white blood cells;
- Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
- Signed informed consent;
- Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
Who cannot join
- Expected Overall survival < 3 months;
- The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
- Liver function is Childs Pugh C;
- Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
- Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai International Medical Center
Shanghai, Shanghai Municipality, 201318
Naiyan Han, +86 (0) 182 1766 2469, naiyan.han@simcgroup.com
About this study
Official title: Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Objectives:
To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.
Read the detailed description
A total of 40 patients may be enrolled over a period of 1-2 years.
- Being tested
- TACE, Precision Cells
- Keywords
- Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
Precision CellsBiological
DC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
| Study group | Role | What they receive |
|---|---|---|
| Precision Cells | Experimental | Precision Cells combined with Transcatheter Arterial Chemoembolization:
Transcatheter Arterial Chemoembolization:
patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells：After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment Receives: Procedure: TACE; Biological: Precision Cells |
| Transcatheter Arterial Chemoembolization | Active comparator | patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Progress-free survival
Measured: 2 years
Secondary outcomes (1)
Quality of life
Questionnaire will be used.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precision CellsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai International Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naiyan Han, Study chair, Shanghai International Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862613
- Sponsor's protocol ID
- SIMC-20160106
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
- ClinicalTrials.gov ID
- NCT02862613
- Acronym / sponsor ID
- SIMC-20160106
- Keywords
- Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai International Medical CenterIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 11 Aug 2016 (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.
Objectives:
To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.
Detailed description
A total of 40 patients may be enrolled over a period of 1-2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision Cells | Experimental | Procedure: TACE, Biological: Precision CellsPrecision Cells combined with Transcatheter Arterial Chemoembolization: Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells：After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment |
| Transcatheter Arterial Chemoembolization | Active comparator | Procedure: TACEpatients will receive MMC,EADM hepatic arterial infusion,6 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18~65 years old, male or female;
- Life expectancy≥6 months;
- ECOG score: 0-3;
- Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
- Enough venous channel, no other contraindications to the separation and collection of white blood cells;
Key exclusion criteria (6 listed)
- Expected Overall survival < 3 months;
- The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
- Liver function is Childs Pugh C;
- Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
- Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
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 |
|---|---|---|
| TACELipiodol 10-20ml,MMC 8～10mg,EADM20～40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion. | Procedure or surgery | Precision Cells, Transcatheter Arterial Chemoembolization |
| Precision CellsDC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63. | Biological | Precision Cells |
Primary outcome
Overall survival
Time frame: 2 years
Progress-free survival
Time frame: 2 years
1 secondary outcome
Quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- 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.
Naiyan Han study chair
Shanghai International Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TACE and Precision Cells in people with Precision Cells and Transcatheter Arterial Chemoembolization, run by Shanghai International Medical Center 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 8 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 2 Sep 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Naiyan Han (+86 21 6023 6666, naiyan.han@simcgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 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 2 Sep 2016.