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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.
A total of 40 patients may be enrolled over a period of 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Transcatheter Arterial Chemoembolization | Active Comparator | patients will receive MMC,EADM hepatic arterial infusion,6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | Lipiodol 10-20ml,MMC 8~10mg,EADM20~40mg.According to tumor area of maximum diameter,0.1~0.2ml/cm2 Hepatic arterial infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years | |
| Progress-free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Questionnaire will be used. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naiyan Han | Contact | +86 21 6023 6666 | naiyan.han@simcgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Naiyan Han | Shanghai International Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai International Medical Center | Recruiting | Shanghai | Shanghai Municipality | 201318 | China |
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| Precision Cells | Biological | 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. |
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