To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors
In the study, 300 advanced primery liver cancer patients who received immune checkpoint inhibitors at first-line setting (N=200) or second-line setting (N=100) will be recruited. By analyzing the ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of ICI treatment, the dynamic changes of bTMB, ctDNA and the composition of immune cells will be detected. Combined with the tumor markers AFP, DCP and CA19-9, a noninvasive multiparameter model will be developed.
Study Type
OBSERVATIONAL
observe the association of ctDNA with efficacy of treatment
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing hospital
Beijing, Beijing Municipality, China
Institute of Hepatopancreatobiliary Surgery, Chongqing General Hospital, University of Chinese Academy of Sciences (UCAS)
Chongqing, Chongqing Municipality, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University
Wuhan, Hubei, China
PFS: Progression-free survival
The time length from the date of randomization to any of the following events: disease progression or death from any cause.
Time frame: 24 months
ORR: Objective Response Rate
The proportion of patients with complete response or partial response.
Time frame: 24 months
OS: Overall Survival
The time length from the date of randomization to the date of death.
Time frame: 24 months
TTD: Time to Treatment Discontinuation
The time length from the date of randomization to the date of treatment discontinuation.
Time frame: 24 months
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Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China