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Objectives:
The purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma.
Methods： This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial chemoembolization group and dendritic cell-precision multiple antigen T cells combined with transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
A total of 60 patients may be enrolled over a period of 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Arterial Chemoembolization | Sham Comparator | Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles. |
|
| DC-PMAT cells | Experimental | After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment. |
|
| 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.Each cycle received one TACE treatment on day 13,34,55. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | 2 years | |
| Quality of life | Quality of life core questionnaire will be used. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qijun Qian, PHD | Contact | +86-21-65580677 | qianqj@sino-gene.cn | |
| Huajun Jin, PHD | Contact | +86-21-81875372 | hj-jin@Hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Shen, PHD | Eastern Hepatobiliary Surgery Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Recruiting | Shanghai | 200438 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16421755 | Background | Cai XY, Gao Q, Qiu SJ, Ye SL, Wu ZQ, Fan J, Tang ZY. Dendritic cell infiltration and prognosis of human hepatocellular carcinoma. J Cancer Res Clin Oncol. 2006 May;132(5):293-301. doi: 10.1007/s00432-006-0075-y. Epub 2006 Jan 19. | |
| 16113606 | Background | Lee WC, Wang HC, Hung CF, Huang PF, Lia CR, Chen MF. Vaccination of advanced hepatocellular carcinoma patients with tumor lysate-pulsed dendritic cells: a clinical trial. J Immunother. 2005 Sep-Oct;28(5):496-504. doi: 10.1097/01.cji.0000171291.72039.e2. |
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| Dendritic Cell | Biological | DC suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. |
|
|
| lipiodol | Drug | lipiodol 10-20ml,hepatic arterial infusion |
|
| Mitomycin (MMC) | Drug | MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion. |
|
| Epirubicin(EADM) | Drug | EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion. |
|
| Precision Multiple Antigen T Cell | Biological | PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 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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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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