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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancancer corhor | No interventions to be administered. |
| |
| Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6 | No interventions to be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions. | Other | No interventions to be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of organoid culture of biopsy samples | The number of successful cases of Organoid culture divided by the number of enrolled cases | 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
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Inclusion Criteria for stage 1:
(5) Understand and sign the informed consent form.
Exclusion Criteria for stage 1:
Inclusion criteria for stage 2:
Exclusion criteria for stage 2:
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Patiens who need to undergo biopsy for malignant tumors such as breast cancer, lung cancer, liver cancer, bile duct cancer or pancreatic cancer that have been clinically and/or pathologically diagnosed.
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| Name | Affiliation | Role |
|---|---|---|
| Liangrong Shi, MD | Xiangya Hospital Central South Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liangrong Shi | Changsha | Hunan | 410008 | China |
not decided yet
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Malignant solid tumor biopsy samples
| 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. |
| 4 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |