Clinical trial NCT05932836: An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: Drug Sensitivity
Organoid-on-chips
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

Eligibility 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.

Primary outcomes:
measure: Success rate of organoid culture of biopsy samples
timeFrame: 2 years
measure: Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in HCC patients with successful Organoid culture
timeFrame: 3 years
Secondary outcomes:
measure: Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in intent-to-treat HCC population
timeFrame: 3 years
measure: The predictive effect of Organoid drug sensitivity test on the survival of patients with HCC.
timeFrame: 4 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Liangrong Shi
state: Hunan
Study officials:
affiliation: Xiangya Hospital Central South Hospital
name: Liangrong Shi, MD
role: STUDY_CHAIR
References: