This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for liver cancer.
Liver cancer is one of the most common malignancies in China, ranking fourth in all malignant tumors and third in mortality. Immunetherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single-center, randomized (1:1of targeted activation CIK and traditional CIK therapy )comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. The investigators plan to recruit for 80 cases patients with advanced liver cancer, the first 20 cases were directly received treatment of activated CIK, and the cases after the 20th were randomly assigned to two group,one of the two group will receive treatment of traditional CIK, and the other receive activated CIK. The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Activated CIK armed with bispecific antibody were infused for 3 days,after 2 days,bispecific antibody was infused separately for 3 days
Traditional CIK were infused for 3 days
302 Military Hospital of China
Beijing, Beijing Municipality, China
RECRUITINGOS
Overrall survival.The time of patient from randomization to death caused by any cause.
Time frame: 3 years
PFS
Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.
Time frame: 3 years
TTP
Time tumor progression.The time of patient from randomization to objective progress of the tumor.
Time frame: 1 years
DCR
Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Time frame: 1 years
ORR
Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
Time frame: 1 years
SRR
Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.
Time frame: 1 years
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