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Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.
Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.
The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T cells | Experimental | CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T cell immunotherapy | Biological | Patients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows: Dose 1: 1x10^7/m2 Dose 2: 3x10^7/m2 Dose 3: 1x10^8/m2 The cell numbers are calculated according to CAR-positive T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient with dose limiting toxicity | After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological evaluation of tumor size after CAR- T immunotherapy | Evaluate the therapeutic effect of CAR-T immunotherapy radiological observation of the tumor size after infusion of CAR-T cells. | 3 months |
| Peripheral tumor marker |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Decai Yu, MD | Contact | 8613701585023 | yudecai@nju.edu.cn | |
| Wenfang Tian, PhD | Contact | 8613675104348 | tiancpu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| C537340 | Simpson-Golabi-Behmel syndrome |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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After CAR-T cell infusion, alpha fetoprotein (AFP) will be tested regularly in blood.
| 3 months |
| Number of Peripheral CAR-T cell | The number and proliferation in vivo are tested with Flow Cytometry regularly. | 3 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |