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

Hepatocellular Carcinoma Clinical Trial

Official title:

An Pancancer Study on Organoid-on-chips Technological System Based on Biopsy Samples and Its Efficacy in Predicting the Response to mFOLFOX6 Infusion in Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932836
• Other study ID #: DX11330
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: February 2023
• Source: Xiangya Hospital of Central South University
• Contact: Fei Liu, MD
• Phone: +8613467569441
• Email: liufei200207[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Exclusion criteria for stage 2:

1. Patients who have had or are currently suffering from other malignant tumors (except for cured basal or squamous cell skin cancer or cervical in situ cancer);

2. White blood cell count <2.5×10^9/L or platelet count <50×10^9/L.

3. Renal dysfunction (creatinine>2mg/L).

4. Liver dysfunction (Child-Pugh=9 points or bilirubin>75µmol/L).

5. with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias, and grade III-IV heart failure.

6. Poor coagulation function INR>1.5, or undergoing anticoagulant therapy or known bleeding disorders.

7. Uncontrollable systemic infection.

8. Patients who underwent chemotherapy, immunotherapy, antitumor vaccines or other antitumor drugs within 2 months.

9. Complications or social environment that may cause subjects to fail to follow the study plan or even endanger patient safety.

10. Participating in another therapeutic clinical trial at the same time.

11. Pregnant or lactating women.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• No interventions.
No interventions to be administered.

Locations

Country	Name	City	State
China	Liangrong Shi	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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