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

Sponsor
Chengjun Sui,MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05644743
Collaborator
(none)
40
47

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: gemcitabine + cisplatin

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Consistency of organoids and clinical patient responses to drugs [3 years]

    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.

  2. Construction of drug resistance prediction model [3 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chengjun Sui,MD

Investigators

  • Principal Investigator: chengjun sui, dr., Deputy director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chengjun Sui,MD, Deputy Director of the Special Needs Division, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT05644743
Other Study ID Numbers:
  • 202240313
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chengjun Sui,MD, Deputy Director of the Special Needs Division, Eastern Hepatobiliary Surgery Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2022