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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer cells escaping from immune surveillance and constructs an immunosuppressive microenvironment. Correspondingly, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.
Detailed Description Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 600 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, control group will receive radical surgery or TACE or targeted agent treatment solely; another group (experimental group) after enrollment will radical surgery or TACE or targeted agent treatment in the first course. Then 20ml blood is taken for multiple signals loaded dendritic cells (MSDCV) culture (cell culture takes 7 days). Low dose (250mg/m^2) CY treatment will be performed on patients two days before the MSDCV treatment. The MSDCV combined CY therapy will perform per 4 weeks, total 6 times. All patients are evaluated the safety and efficacy of treatment by monitoring their blood parameters, tumor indicators and imaging examinations at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSDCV immune therapy combined with radical surgery therapy | Experimental | Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy:one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, total 6 times; Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time before the first time of MSDCV immune therapy |
|
| Radical surgery therapy | No Intervention | Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time | |
| MSDCV immune therapy combined with TACE therapy | Experimental | Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy:one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, total 6 times; Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: the first time of TACE therapy must perform before the first time of MSDCV immune therapy, then perform when necessary according to subjects condition |
|
| TACE therapy | No Intervention | Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: perform when necessary according to Subjects condition | |
| MSDCV immune therapy combined with targeted agents therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Intravenous drip,250mg/m^2 per time,two days before each times of MSDCV therapy,total 6 times, in order to improve the immunosuppressive microenvironment of tumor,reduce CD4+CD25+FOXP3+regulatory T cells (Tregs) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival (PFS), month | The time from randomization until first documented progression or death from any cause,whichever came first | 240 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| serum AFP(alpha fetoprotein), ng/ml | Measured for each subjects at each visits | 240 weeks |
| serum PIVKA-II(Protein Induced by Vitamin K Absence or Antagonist-II), μg/L | Measured for each subjects at each visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehua HYuang, doctorate | Contact | 0086-13822232795 | huangyh53@mail.sysu.edu.cn | |
| Yifan Lian, doctorate | Contact | 0086-13824441190 | lianyf@mail3.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yuehua Huang, doctorate | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Experimental |
Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy:one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, total 6 times; Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition |
|
| Targeted agents therapy | No Intervention | Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition |
|
| Multiple Signals loaded Dendritic Cells Vaccine | Biological | one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, intravenous driptotal 6 times; |
|
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| 240 weeks |
| Overall Survival (OS), month | The time from random assignment to death from any cause | 240 weeks |
| tumor size, mm | Utilizing Liver CT or MR examination | 240 weeks |
| Number of participants with treatment-related adverse events | Assessed by CTCAE v4.0 | 240 weeks |
| Sun Yat-sen University Cancer center | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| The Third Affiliated Hospital of Zhongshan University | Recruiting | Guangzhou | Guangdong | 510630 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |