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

NCT ID: NCT05644743

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Organoids Intrahepatic Cholangiocarcinoma

Keywords

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Organoid

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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gemcitabine + cisplatin

Gemcitabine intravenous drip, day 1, 8； Cisplatin intravenous drip, day 1； 3 weeks is a cycle, and 6 cycles are used continuously.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengjun Sui,MD

OTHER

Sponsor Role lead

Responsible Party

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Chengjun Sui,MD

Deputy Director of the Special Needs Division

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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chengjun sui, dr.

Role: PRINCIPAL_INVESTIGATOR

Deputy director

Central Contacts

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zhitao dong, dr.

Role: CONTACT

Phone: +86-021-81875554

Email: [email protected]

kunpeng fang, dr.

Role: CONTACT

Phone: +86-021-81875553

Email: [email protected]

Other Identifiers

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202240313

Identifier Type: -

Identifier Source: org_study_id