This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 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 bispecific antibody for liver cancer.
Primary hepatocellular carcinoma is one of the most common malignancies in China, ranking fourth in all malignant tumors and third in mortality.immunotherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single- center, The investigators plan to recruit for 90 patients with advanced liver cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive Non-intervention therapy,and the rest one will receive mixed liquor of activated CIK and anti-CD3-MUC1 bispecific antibody together with cryotherapy. 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
CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, China
Institutional Review Board of Guangzhou Fuda Cancer Hospital
Guangzhou, Guangdong, China
Objective response rate
ORR.The proportion of patients who had a best response rating of complete response and partial response.
Time frame: 1 year
Progression-free survival
PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.
Time frame: 3 years
Time tumor progression
TTP.The time of patient from randomization to objective progress of the tumor.
Time frame: 1 year
Disease control rate
DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.
Time frame: 1 year
Overall survival
OS.The time of patient from randomization to death caused by any cause
Time frame: 3 years
Symptom remission rate
SRR. The proportion of symptoms are alleviated in all evaluative cases.
Time frame: 1 year
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