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NCT05932836Completed

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

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
226 (actual)
First submitted
27 Jun 2023
Start date
1 Mar 2023
Primary completion date
28 Aug 2024
Lead sponsor
Xiangya Hospital of Central South University
NCT number
NCT05932836

What you commit to

  • Study type: Observational
  • Participants enrolled: 226
  • From 1 Mar 2023 to the primary completion date, 28 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Severe heart and lung dysfunction。
  • Irreversible bleeding tendency.
  • 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);
  • with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias, and grade III-IV heart failure.
  • Uncontrollable systemic infection.

Lab values

  • 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).
  • Poor coagulation function INR\>1.5, or undergoing anticoagulant therapy or known bleeding disorders.

Other

  • There are obvious infectious lesions or important structures that cannot be avoided along the puncture path.
  • Complications or social environment that may cause subjects to fail to follow the study plan or even endanger patient safety.
  • Participating in another therapeutic clinical trial at the same time.
  • Pregnant or lactating women.

Who the study is looking for

  • 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.
  • Age 18-75 years old.
  • Hepatocellular carcinoma (HCC) confirmed by pathological histology BCLC stage C or CNLC stage IIIA and treated by hepatic artery infusion with mFOLFOX6.
  • At least one lesion that can be evaluated by RECIST 1.1 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liangrong Shi
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.