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This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor-infiltrating Lymphocytes Therapy | Experimental | Autologous Tumor-infiltrating Lymphocytes Therapy, 2.0*10^7/Kg, single intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tumor-infiltrating Lymphocytes | Procedure | Autologous Tumor-infiltrating Lymphocytes, 2.0*10^7/Kg, single intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy | day0, day3, week1, week2, week4, week12, week24 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Total Bilirubin (TBIL, mg/dL) | Total bilirubin refers to the concentration of bilirubin in a patient's blood sample, which is automatically measured by the laboratories in accordance with standard operating procedures. | day0, day3, week1, week2, week4, week12, week24 |
| Child-Turcotte-Pugh(CTP) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junliang Fu, PhD, MD | Contact | 86-10-66933214 | fjunliang@163.com | |
| Fu-Sheng Wang, PhD, MD | Contact | 86-10-66933328 | fswang302@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junliang Fu, PhD, MD | the Fifth Medical Center of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Fifth Medical Center of PLA | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Autologous Tumor-infiltrating Lymphocytes Therapy
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CTP score is currently the most commonly used model to evaluate liver reserve function and prognosis in patients with cirrhosis. This model evaluates liver function based on HE grade, degree of abdominal fluid accumulation, bilirubin (TBiL), albumin (Alb) and prothrombin time (PT). The score ranges from 0 to 15, with the higher the score, the worse the prognosis. |
| day0, day3, week1, week2, week4, week12, week24 |
| Quality of life of patients | Quality of life assessed by Functional Assessment of Cancer Therapy - Hepatobiliary Symptom Index, which has a score ranges 0-32, a higher score indicates better quality of life. | day0, day3, week1, week2, week4, week12, week24 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |