An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC
NCT ID: NCT05932836
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
165 participants
OBSERVATIONAL
2023-03-01
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pancancer corhor
No interventions to be administered.
No interventions.
No interventions to be administered.
Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6
No interventions to be administered.
No interventions.
No interventions to be administered.
Interventions
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No interventions.
No interventions to be administered.
Eligibility Criteria
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Inclusion Criteria
2. ECOG score ≤ 2.
3. Age between 18-75 years old.
(5) Understand and sign the informed consent form.
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
2. Irreversible bleeding tendency.
3. There are obvious infectious lesions or important structures that cannot be avoided along the puncture path.
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.
18 Years
75 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Liangrong Shi, MD
Role: STUDY_CHAIR
Xiangya Hospital Central South Hospital
Locations
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Liangrong Shi
Changsha, Hunan, China
Countries
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Other Identifiers
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DX11330
Identifier Type: -
Identifier Source: org_study_id
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