Early clinical trials on evaluating the tolerance, safety and efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Tumor infiltrating lymphocytes were isolated from tumor tissues from tumor biopsy or operation. These TILs were cultured in human IL-2 medium for 4 to 5 weeks. 10e9 to 10e10 TILs were yielded. The phenotype, function and sterile were detected before these TILs infused patients.
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
DLT
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Time frame: 24 months
Progression-Free Survival
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Time frame: 24 months
Overall Survival Overall Survival
To evaluate the efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Time frame: 24 months
EQ-5D score
To evaluate the efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Time frame: 24 months
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