Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05644743
• Other study ID #: 202240313
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: December 2026

Study information

• Verified date: November 2022
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: zhitao dong, dr.
• Phone: +86-021-81875554
• Email: dongzt2012[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Organoids

Intervention

Device:
• gemcitabine + cisplatin
Gemcitabine intravenous drip, day 1, 8; Cisplatin intravenous drip, day 1; 3 weeks is a cycle, and 6 cycles are used continuously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengjun Sui,MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistency of organoids and clinical patient responses to drugs	A total of 20 unresectable ICC patients were selected and biopsies were performed before treatment to construct organoid models. All patients were treated with GC chemotherapy. Drug responses of organoids and clinical patients were compared to determine the feasibility of in vitro organoid culture as a drug screening platform. The samples of 3 patients who were sensitive to GC and 3 patients who were resistant to GC were sequenced to search for drug-resistant genes, and the differential drug-resistant genes were studied in vitro.	3 years
Primary	Construction of drug resistance prediction model	A total of 20 patients with advanced unresectable ICC were selected to verify whether they participated in drug resistance by combining 1-2 drug resistance genes previously screened and the currently recognized platinum-based drug resistance genes. The results were compared with those of organoid models to build an organoid-based drug resistance prediction model.	3 years