Active — Not RecruitingNot Applicable

An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC

China165 participantsStarted 2023-03-01

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Severe heart and lung dysfunction。
✕. Irreversible bleeding tendency.
✕. There are obvious infectious lesions or important structures that cannot be avoided along the puncture path.
✕. Age 18-75 years old.
✕. 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.
✕. 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).
✕. Liver function Child-Pugh A or B level (≤8 points).
✕. ECOG PS ≤ 2 points.

What they're measuring

Success rate of organoid culture of biopsy samples

Timeframe: 2 years

Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in HCC patients with successful Organoid culture

Timeframe: 3 years

Trial details

NCT IDNCT05932836

SponsorXiangya Hospital of Central South University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials