Hepatocellular Carcinoma
Conditions
Keywords
Drug Sensitivity, Organoid-on-chips
Brief summary
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).
Detailed description
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).
Interventions
OTHERNo interventions.
No interventions to be administered.
Sponsors
Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
for stage 1: 1. Patients who need to undergo biopsy for clinically and/or pathologically diagnosed (suspected) with malignant solid tumors including breast cancer, lung cancer, liver cancer, bile duct cancer or pancreatic cancer, et.al. 2. ECOG score ≤ 2. 3. Age between 18-75 years old. (5) Understand and sign the informed consent form.
Exclusion criteria
for stage 1： 1. Severe heart and lung dysfunction。 2. Irreversible bleeding tendency. 3. There are obvious infectious lesions or important structures that cannot be avoided along the puncture path. Inclusion criteria for stage 2: 1. Age 18-75 years old. 2. Hepatocellular carcinoma (HCC) confirmed by pathological histology BCLC stage C or CNLC stage IIIb; or BCLC B or CNLC IIb stage HCC progressed after previous local treatment (surgery, TACE/TAE and ablation); and treated by hepatic artery infusion with mFOLFOX6. 3. At least one lesion that can be evaluated by mRECIST criteria; lesions that have undergone local treatment (TACE/TAE, ablation, radiotherapy) should not be included (unless there is progression at baseline assessment at entry, in which case it should be classified as non-target lesions/unmeasurable lesions). 4. Liver function Child-Pugh A or B level (≤8 points). 5. ECOG PS ≤ 2 points. 6. Expected survival time \> 3 months. 7. Understand and sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of organoid culture of biopsy samples | 2 years | The number of successful cases of Organoid culture divided by the number of enrolled cases |
| Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in HCC patients with successful Organoid culture | 3 years | The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in HCC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in intent-to-treat HCC population | 3 years | 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 |
| The predictive effect of Organoid drug sensitivity test on the survival of patients with HCC. | 4 years | The predictive role of Organoid drug sensitivity test results and the survival period of patients with HCC receiving mFOLFOX6 infusion. |
Countries
China
Outcome results
None listed