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Trial Title:
An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC
NCT ID:
NCT05932836
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Drug Sensitivity
Organoid-on-chips
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No interventions.
Description:
No interventions to be administered.
Arm group label:
Hepatocellular carcinoma patients who undergo hepatic artery infusion with mFOLFOX6
Arm group label:
Pancancer corhor
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).
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).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liangrong Shi
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
Liangrong Shi
Start date:
March 1, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Source:
Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05932836
