Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or refractory liver cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
This is a single-arm,multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for Liver Cancer.The study will be conducted using a phaseâ… /â…¡ disign.The study will have the following sequential phases:Part A(screening leukapheresis,cell product preparation,and cytoreductive chemotherapy) and Part B(treatment and follow-up).The follow-up period for each paticipant is approximately 35 months after the final CAR-T infusion.The total duration of the study is expected to be approximately 3 years.A total of 25 patients may be enrolled over a period of 3 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:0 days,the first day,the second day,28days,29days Duration:total five times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPCAM-targeted CAR-T cells | Biological | This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rates | Tumor complete remission number + partial response number + number of stable disease /Total number of cases being treated | CAR - T back to lose 0 days to 180 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianping Cheng, PI | Contact | 13805512522 | chengxianping@sina.com | |
| mo chen, Investigator | Contact | 13605511023 | chemo@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianping Cheng, PI | associate chief physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui No.2 Province People's Hospital | Recruiting | Hefei | Anhui | 230000 | China |
No plans to share data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D008107 |
| Liver Diseases |