Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer

NCT ID: NCT03170180

Last Updated: 2022-06-15

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-12-28

Brief Summary

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1. Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study.
2. After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib).
3. Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and patients will be treated with sensitive drugs.
4. Patients will be evaluated every 6 weeks.

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sunitinib

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

sunitinib 37.5mg daily

gefitinib

Group Type EXPERIMENTAL

Gefitinib

Intervention Type DRUG

Gefitinib 250mg daily

imatinib

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

Imatinib 400mg daily

Interventions

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Sunitinib

sunitinib 37.5mg daily

Intervention Type DRUG

Gefitinib

Gefitinib 250mg daily

Intervention Type DRUG

Imatinib

Imatinib 400mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age\>-20
* metastatic gastric cancer
* life expectancy \>-3 months
* ascites and pleural effusion that can be drained
* ECOG 0-2
* Proper organ function
* Patients who will be enrolled in sunitinib, gefitinib, imatinib clinical trial

Exclusion Criteria

* HBeAg, HCV, HIV (+)
* Active infection
* Uncontrolled systemic disease
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeeyun Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeeyun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2016-12-058

Identifier Type: -

Identifier Source: org_study_id

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