The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related death worldwide. The resection rate for HCC is approximately 10%-30% and the overall prognosis is very poor with a 5-year survival rate of 5%-6%. The recurrence rate is high after radical resection. In addition to surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), microwave ablation, cryoablation, radioactive seeds implantation, high-intensity-focused ultrasound, radiation therapy, chemotherapy and targeted drugs are available for patients with unresectable tumors; however, the efficacy of these treatments are limited and long-term prognosis in the patients is still poor. Moreover, due to serious side effects induced by treatments such as TACE, chemotherapy and targeted drugs, it may not be possible for patients to continue receiving these therapies. The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory. NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4-6 doses.
Radiotherapy of the major mass by dose of 5Gy/F \* 10F
Number of participants with Adverse Events
using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Time frame: up to 6 months
Response Rate
Response Rate(RR) will be evaluated according Response Evaluation Criteria
Time frame: 3, 6 and 12 months
Progression free survival (PFS)
the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented
Time frame: 3, 6, 9 and 12 months
Overall Survival (OS)
the duration is measured from the time of treatment to the time of death
Time frame: At 6, 12 and 18 months
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