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

NCT05932836 | Active Not Recruiting

• 1 other identifier: DX11330
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatocellular Carcinoma

Keywords

Drug Sensitivity; Organoid-on-chips

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in intent-to-treat HCC population

  3 years

• The predictive effect of Organoid drug sensitivity test on the survival of patients with HCC.

  4 years

Study Arms (2)

Pancancer corhor

No interventions to be administered.

Other: No interventions.

Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6

No interventions to be administered.

Other: No interventions.

Interventions

No interventions. OTHER

No interventions to be administered.

Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6; Pancancer corhor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• ECOG score ≤ 2.
• Age between 18-75 years old.
• (5) Understand and sign the informed consent form.

You may not qualify if:

• Severe heart and lung dysfunction。
• Irreversible bleeding tendency.
• There are obvious infectious lesions or important structures that cannot be avoided along the puncture path.
• Age 18-75 years old.
• 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.
• 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).
• Liver function Child-Pugh A or B level (≤8 points).
• ECOG PS ≤ 2 points.
• Expected survival time \> 3 months.
• Understand and sign the informed consent form.
• 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);
• White blood cell count \<2.5×10\^9/L or platelet count \<50×10\^9/L.
• Renal dysfunction (creatinine\>2mg/L).
• Liver dysfunction (Child-Pugh≥9 points or bilirubin\>75μmol/L).
• with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias, and grade III-IV heart failure.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Liangrong Shi

Changsha, Hunan, 410008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Malignant solid tumor biopsy samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Liangrong Shi, MD

  Xiangya Hospital Central South Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)