Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Ningbo Cancer Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Precision Cell Immunotherapy; Advanced Liver Cancer; Transcatheter Arterial Chemoembolization

Treatments: Procedure: TACE; Biological: Precision Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873442

NBWYKY2016-06-005

Details and patient eligibility

About

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.

Full description

A total of 40 patients may be enrolled over a period of 1-2 years.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Precision cells combined with TACE

Experimental group

Description:

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

Treatment:

Procedure: TACE

Biological: Precision Cells

Transcatheter Arterial Chemoembolization

Active Comparator group

Description:

patients will receive MMC,EADM hepatic arterial infusion,6 cycles.

Treatment:

Procedure: TACE