Combination treatment with antiangiogenic agents and anti-programmed cell death protein 1 (PD-1) antibodies have shown high anti-tumor efficacy for patients with unresectable or advanced hepatocellular carcinoma (uHCC). In this single-center cohort study, we are aiming to (1) evaluate the clinical effectiveness in real-world patients, especially for Chinese patients, most of whom were with hepatitis B virus infection; (2) predict clinical effectiveness with clinicopathological features; (3) predict clinical effectiveness with histologic features and blood samples.
Combination treatment with antiangiogenic agents and anti-programmed cell death protein 1 (PD-1) antibodies have shown high anti-tumor efficacy for patients with unresectable or advanced hepatocellular carcinoma (uHCC). In this single-center cohort study, we are aiming to: 1. To evaluate the clinical effectiveness in real-world patients, especially for Chinese patients most of whom were with hepatitis B virus infection. 2. To predict clinical effectiveness with clinicopathological features, such as lab examinations (at baseline and dynamic changes), radiological features (radiomics study at the baseline); 3. To predict clinical effectiveness with histologic features, such as PD-L1 expression, ctDNA, and peripheral immune cell subtypes. 4. To evaluate the clinical effectiveness of second- or third-line therapies, including TACE, HAIC, and interferon, for those who lost clinical benefit or who were intolerant to the combination therapy.
Study Type
OBSERVATIONAL
Enrollment
200
Combination therapies with an anti-angiogenic agent (tyrosine kinase inhibitor or VEGF/VEGFR antibody) and an anti-PD-1/PD-L1 antibody.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response
Subjects with complete response or partial response
Time frame: up to 2 years
Duration of response
the interval between the time of partial or complete response to the time of progressive disease
Time frame: up to 2 years
Progression free survival
the interval between the time of treatment initiation to the time of progressive disease or patient death
Time frame: up to 2 years
Overall survival
the interval between the time of treatment initiation to the time of patient death
Time frame: up to 2 years
Ratio of R0 resection
The ratio of patients who underwent R0 resection to patients received combination therapy
Time frame: up to 2 years
Recurrence-free survival
the interval between the time of surgical resection to the time of disease recurrence or patient death for those who underwent surgery
Time frame: up to 5 years
Time to deterioration in patient-reported quality of life, physical functioning, and role functioning
Quality of life, physical functioning, and role functioning was determined by EORTC QLQ-C30 and QLQ-HCC18 questionnaires.
Time frame: up to 2 years
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