Predicting the Efficacy in Advanced Gastric Cancer.

NCT ID: NCT06490055

Last Updated: 2025-07-18

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

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2025-07-01

Brief Summary

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With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer.

Detailed Description

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The combination of paclitaxel and ramucirumab is a potent standard second-line therapy for patients with advanced gastric cancer, but approximately 30% of patients do not respond to treatment. Failure to respond to second-line therapy can lead not only to disease progression, but also to deterioration of the patient's health and loss of the opportunity to receive other treatments that originally had the potential to be curative. This study aims to predict the efficacy of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). Prediction using pre-treatment blood may allow patients who do not respond to treatment to choose other treatment options. This study aims to establish a tool that will enable noninvasive pre-treatment selection, which could lead to personalized treatment.

Conditions

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Gastric Cancer Chemotherapy Effect Paclitaxel Ramucirumab

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gastric cancer chemotherapy responders received second-line chemotherapy

Responders according to the response evaluation criteria in solid tumors (RECIST).

A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)

Paclitaxel

Intervention Type DRUG

Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)

Gastric cancer chemotherapy non-responders received second-line chemotherapy

Non-responders according to the response evaluation criteria in solid tumors (RECIST).

A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)

Paclitaxel

Intervention Type DRUG

Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)

Interventions

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Paclitaxel

Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)

Intervention Type DRUG

Other Intervention Names

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Ramucirumab

Eligibility Criteria

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Inclusion Criteria

1. unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach.
2. age over 20 years.
3. Eastern Cooperative Oncology Group performance status score of 0-2.
4. written informed consent following full study information is provided to the patient.
5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.

Exclusion Criteria

1. Patients with a life expectancy of shorter than 3 months
2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
3. Patients with a history of serious allergic reactions or serious drug allergy.
4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koichi Takiguchi, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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Department of Molecular Diagnostics and Experimental Therapeutics

Monrovia, California, United States

Site Status

Kawasaki Medical University

Kurashiki, Okayama-ken, Japan

Site Status

Countries

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United States Japan

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Other Identifiers

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23228/SLCGC

Identifier Type: -

Identifier Source: org_study_id

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