Hepatocellular CarcinomaNCT05932836
An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC
An observational study of Hepatocellular Carcinoma, run by Xiangya Hospital of Central South University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 28 May 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- Severe heart and lung dysfunction。
- Irreversible bleeding tendency.
- There are obvious infectious lesions or important structures that cannot be avoided along the puncture path.
- 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).
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- 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.
- Poor coagulation function INR>1.5, or undergoing anticoagulant therapy or known bleeding disorders.
- Uncontrollable systemic infection.
- Patients who underwent chemotherapy, immunotherapy, antitumor vaccines or other antitumor drugs within 2 months.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- No interventions.
- Keywords
- Drug Sensitivity, Organoid-on-chips
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions.Other
No interventions to be administered.
| Study group | Role | What they receive |
|---|---|---|
| Pancancer corhor | No interventions to be administered. Receives: Other: No interventions. | |
| Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6 | No interventions to be administered. Receives: Other: No interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of organoid culture of biopsy samples
The number of successful cases of Organoid culture divided by the number of enrolled cases
Measured: 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 (RECIST 1.1) to mFOLFOX6 infusion in HCC
Measured: 3 years
Secondary outcomes (2)
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
Measured: 3 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Mar 2023
- Primary completion28 Aug 2024
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangrong Shi, MD, Study chair, Xiangya Hospital Central South Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932836
- Sponsor's protocol ID
- DX11330
- Status last verified
- Jan 2025
- First submitted
- 27 Jun 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05932836
- Acronym / sponsor ID
- DX11330
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Drug Sensitivity, Organoid-on-chips
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancancer corhor | – | Other: No interventions.No interventions to be administered. |
| Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6 | – | Other: No interventions.No interventions to be administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
- Understand and sign the informed consent form.
- Age 18-75 years old.
Key exclusion criteria (14 listed)
- Severe heart and lung dysfunction。
- Irreversible bleeding tendency.
- There are obvious infectious lesions or important structures that cannot be avoided along the puncture path.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions.No interventions to be administered. | Other | Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6, Pancancer corhor |
Primary outcome
Success rate of organoid culture of biopsy samples
Time frame: 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
Time frame: 3 years
The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response (RECIST 1.1) to mFOLFOX6 infusion in HCC
2 secondary outcomes
Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in intent-to-treat HCC population
Time frame: 3 years
The predictive effect of Organoid drug sensitivity test on the survival of patients with HCC.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangrong Shi, MD study chair
Xiangya Hospital Central South Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of organoid culture of biopsy samples (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.