This study is aimed to establish an organoid-on-chips technological system based on biopsy samples and evaluate its efficacy in predicting the response to mFOLFOX6 infusion in patients with hepatocellular carcinoma (HCC).
This is a two-stage, multi-center real-world observational study. In stage 1, we aim to establish the technical system of organoid-on-chips culture system based on biopsy samples from patients with malignant solid tumors including breast cancer, lung cancer, liver cancer, bile duct cancer and pancreatic cancer, et.al. In stage 2, we aim to evaluate the predicting efficacy of the established organoid-on-chips system in HCC patients who undergo hepatic artery infusion (HAI) with mFOLFOX6 (oxaliplatin 85mg/m\^2, d1, HAI for 2h; calcium folinate 200mg/m\^2, d1, HAI for 1h; fluorouracil 400mg/m\^2, hepatic artery injection; fluorouracil 2400mg/m\^2, HAI for 46h).
Study Type
OBSERVATIONAL
Enrollment
165
No interventions to be administered.
Liangrong Shi
Changsha, Hunan, China
Success rate of organoid culture of biopsy samples
The number of successful cases of Organoid culture divided by the number of enrolled cases
Time frame: 2 years
Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in HCC patients with successful Organoid culture
The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in HCC
Time frame: 3 years
Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in intent-to-treat HCC population
The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in intent-to-treat HCC population
Time frame: 3 years
The predictive effect of Organoid drug sensitivity test on the survival of patients with HCC.
The predictive role of Organoid drug sensitivity test results and the survival period of patients with HCC receiving mFOLFOX6 infusion.
Time frame: 4 years
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