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Trial Title:
Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma
NCT ID:
NCT05644743
Condition:
Organoids
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Gemcitabine
Conditions: Keywords:
Organoid
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
gemcitabine + cisplatin
Description:
Gemcitabine intravenous drip, day 1, 8； Cisplatin intravenous drip, day 1； 3 weeks is a
cycle, and 6 cycles are used continuously.
Summary:
The clinical incidence of intrahepatic cholangiocarcinoma (ICC) is high and insidious,
and the prognosis of advanced patients is poor. The clinical manifestations of
traditional chemotherapy GC and emerging targeted therapy are different in most patients,
and there is still no effective scheme to evaluate the differences in individual patient
reactivity. Patient-derived tumor organoids (PDO) are 3D-cultured tissues based on tumor
cell dryness that reproduce a variety of biological characteristics of parental tumors in
vitro and have similar drug responsiveness to tumors in vivo. This project plans to use
clinical cases and optimized organoid culture system to first construct relevant
organoids from unresectable ICC patient puncture samples. Secondly, based on the organoid
model of intrahepatic cholangiocarcinoma, the clinical efficacy of GC regimen was
predicted, and in vitro and in vivo drug screening was conducted to explore the guidance
of patient-derived tumor organoids for clinical treatment. Then, multi-omics data of
organoids and in vitro and in vivo drug efficacy evaluation model were used to explore
the drug resistance genes of intrahepatic cholangiocarcinoma, providing the basis for
personalized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma.
Criteria for eligibility:
Study pop:
All patients were histologically or cytologically diagnosed with locally advanced
inoperable radical resectable or metastatic intrahepatic cholangiocarcinoma.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Histologically confirmed intrahepatic cholangiocarcinoma They are between 18 and 80
years old Written informed and signed consent form Biopsy sample of the intrahepatic
bile duct
Exclusion Criteria:
- Under 18, over 80 Informed consent cannot be given Biopsy samples were not available
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
January 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Chengjun Sui,MD
Agency class:
Other
Source:
Eastern Hepatobiliary Surgery Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05644743
