Clinical trial NCT02873442: Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
Official title: Clinical Study Using Precision Cell Immunotherapy Combination With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Precision Cell Immunotherapy
Transcatheter Arterial Chemoembolization
Advanced Liver Cancer
Keywords: Precision Cell Immunotherapy
Transcatheter Arterial Chemoembolization
Advanced Liver Cancer
Lead sponsor: Ningbo Cancer Hospital
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18\~65 years old, male or female;
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:

1. Expected Overall survival \< 3 months
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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo No.5 Hospital (Ningbo Cancer Hospital)
state: Zhejiang
Study officials:
affiliation: Shanghai Cell Therapy Research Institute
name: Huajun Jin
role: STUDY_CHAIR
affiliation: Shanghai Cell Therapy Research Institute
name: Qijun Qian
role: STUDY_CHAIR
affiliation: Ningbo No.5 Hospital (Ningbo Cancer Hospital)
name: Jiangtao Wang
role: STUDY_DIRECTOR
References: