No interventions.: No interventions to be administered.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Success rate of organoid culture of biopsy samples — 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 — 3 years The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in HCC
Trial sites (1)
Facility
City
Region
Status
Liangrong Shi
Changsha
Hunan
More Xiangya Hospital of Central South University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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