Advanced Hepatocellular Carcinoma, Recurrence Hepatocellular Carcinoma
Conditions
Keywords
Recurrence Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Dendritic Cell -Precision Multiple Antigen T Cells, Transcatheter Arterial Chemoembolization
Brief summary
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.
Detailed description
A total of 60 patients may be enrolled over a period of 1-2 years.
Interventions
PROCEDURETACE
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.
BIOLOGICALDendritic Cell
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.
DRUGlipiodol
lipiodol 10-20ml,hepatic arterial infusion
DRUGMitomycin (MMC)
MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.
DRUGEpirubicin(EADM)
EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.
BIOLOGICALPrecision Multiple Antigen T Cell
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.
Sponsors
Second Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 65 years old, male or female 2. Signed informed consent 3. Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out. 4. The recurrence of HCC was found after the operation without distant metastasis. 5. The Eastern Cooperative Oncology Group (ECOG) score ≤2 6. Child-Pugh score of liver function ≤ 9 7. Routine blood meets the requirements.
Exclusion criteria
1. Expected Overall survival \< 3 months 2. The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus 3. Liver function is Childs Pugh C 4. Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney 5. Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. 6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress-free survival | 2 years | — |
| Quality of life | 2 years | Quality of life core questionnaire will be used. |
Countries
China
Contacts
Primary ContactQijun Qian, PHD
Backup ContactHuajun Jin, PHD
Outcome results
None listed