An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: No interventions.

• Registration Number: NCT05932836
• Lead Sponsor: Xiangya Hospital of Central South University

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).

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Primary Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6	No interventions.	No interventions to be administered.
Pancancer corhor	No interventions.	No interventions to be administered.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Liangrong Shi; 🇨🇳 Changsha, Hunan, China