Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
NCT ID: NCT02873442
Last Updated: 2016-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
NCT02862613
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
NCT02862587
Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo
NCT07239245
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
NCT01828762
TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
NCT02630108
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Precision cells combined with TACE
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
TACE
Lipiodol 10-20ml,MMC 8～10mg,EADM20～ 40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
Precision Cells
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 Cell suspension (1-6×109 PMAT/PNAT + 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.
Transcatheter Arterial Chemoembolization
patients will receive MMC,EADM hepatic arterial infusion,6 cycles.
TACE
Lipiodol 10-20ml,MMC 8～10mg,EADM20～ 40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TACE
Lipiodol 10-20ml,MMC 8～10mg,EADM20～ 40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
Precision Cells
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 Cell suspension (1-6×109 PMAT/PNAT + 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. 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;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. 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；
7. Signed informed consent；
8. 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.
Exclusion Criteria
2. The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
3. Liver function is Childs Pugh C
4. Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
5. Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ningbo Cancer Hospital
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huajun Jin
Role: STUDY_CHAIR
Shanghai Cell Therapy Research Institute
Qijun Qian
Role: STUDY_CHAIR
Shanghai Cell Therapy Research Institute
Jiangtao Wang
Role: STUDY_DIRECTOR
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Ningbo, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jiangtao Wang
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NBWYKY2016-06-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.