Hepatocellular CarcinomaPhase 1/2NCT03124498
A Study to Evaluate Autologous CIK Cells in Patients With Hepatocellular Carcinoma After TACE, PEIT or RFA
A Phase 1/2 study testing CIK Cell in people with Hepatocellular Carcinoma, run by Chuan An Biotechnology Co., Ltd..
Trial summary
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CIK Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Jun 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 to 80 years old men and women;
- HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy;
- Patients who are not a transplant candidate;
- Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy;
- Patients who have a life expectancy of at least 6 months;
- Child-Pugh Class should be A or B;
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- Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3;
- Patients who have clinical laboratory test results as follows:
- Absolute neutrophil count ≥ 1,500/µL or White blood cell ≥ 4,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Platelet count ≥ 50,000/µL
- Blood creatinine ≤ 1.5 x upper limit of normal
- Total bilirubin < 3 x upper limit of normal
- Albumin ≥ 2.8 g/dL
- International normalized ratio (INR) / Partial thromboplastin time (PTT) < 1.5 x upper limit of normal
- Written informed consent.
Who cannot join
- Patients who have infiltrative or diffuse HCC;
- Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease;
- Patients who plan to receive systemic chemotherapy or target therapy;
- Patients with other malignant tumor within the past 5 years before treatment;
- Pregnant or lactating patients;
- Patients with hemorrhage/bleeding event;
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- Patients with uncontrolled infections;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Patients who have current Human Immunodeficiency Virus (HIV) or Treponema Pallidum (TP) infection;
- Patients who are suffering from serious autoimmune disease;
- Patients who have had long term use of or are using an immunosuppressant;
- History of organ transplant;
- Prior use of any anti-cancer treatments within 30 days or 5 half-lives (whichever is longer), except TACE, PEIT and RFA therapy;
- Patients who have participated in another clinical study and received treatment within 30 days prior to the screening visit;
- Mental conditions rendering the patient incapable of understanding the nature, scope, and consequences of the study;
- Other situations that the researchers considered unsuitable for this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients With Hepatocellular Carcinoma (HCC) After Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CIK Cell
- Keywords
- Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIK CellBiological
Autologous cytokine-induced killer (CIK) cell
| Study group | Role | What they receive |
|---|---|---|
| CIK Cell | Experimental | Phase I - Three dose levels escalated according to 3+3 rule
Phase II - The recommended dose level according to the results from Phase I Receives: Biological: CIK Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Presence or absence of Dose-Limiting Toxicity
Measured: 5 Weeks
Phase II: Disease Control Rate
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startNov 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuan An Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124498
- Sponsor's protocol ID
- CABIO-CIK-1701
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients With Hepatocellular Carcinoma (HCC) After Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy
- ClinicalTrials.gov ID
- NCT03124498
- Acronym / sponsor ID
- CABIO-CIK-1701
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Chuan An Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 21 Apr 2017 (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.
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIK Cell | Experimental | Biological: CIK CellPhase I - Three dose levels escalated according to 3+3 rule Phase II - The recommended dose level according to the results from Phase I |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 20 to 80 years old men and women;
- HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy;
- Patients who are not a transplant candidate;
- Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy;
- Patients who have a life expectancy of at least 6 months;
Key exclusion criteria (16 listed)
- Patients who have infiltrative or diffuse HCC;
- Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease;
- Patients who plan to receive systemic chemotherapy or target therapy;
- Patients with other malignant tumor within the past 5 years before treatment;
- Pregnant or lactating patients;
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 |
|---|---|---|
| CIK CellAutologous cytokine-induced killer (CIK) cell | Biological | CIK Cell |
Primary outcome
Phase I: Presence or absence of Dose-Limiting Toxicity
Time frame: 5 Weeks
Phase II: Disease Control Rate
Time frame: 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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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 1/2 study testing CIK Cell in people with Hepatocellular Carcinoma, run by Chuan An Biotechnology Co., Ltd..
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 16 inclusion and 16 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 21 Apr 2017. 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 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 Keanyee Lai (+886-02-27928987, laikeanyee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Presence or absence of Dose-Limiting Toxicity (time frame: 5 Weeks). 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 21 Apr 2017.