Predicting the Efficacy in Advanced Gastric Cancer.

July 16, 2025 updated by: City of Hope Medical Center

Predicting the Efficacy of Paclitaxel Plus Ramucirumab in Advanced Gastric Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Okayama
      • Kurashiki, Okayama, Japan, 7010192
        • Kawasaki Medical University
  • United States
    • California
      • Monrovia, California, United States, 91016
        • Department of Molecular Diagnostics and Experimental Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients need second-line chemotherapy with unresectable or recurrent Gastric cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Drug: Paclitaxel
Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)
Other Names:
  • 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)
Drug: Paclitaxel
Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)
Other Names:
  • Ramucirumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy response
Time Frame: 2 years
Follows by response valuation criteria in solid tumors (RECIST) evaluation. Partial response (PR) and Stable disease (SD) are defined as treatment effective, while Progressive disease (PD) is defined as no treatment effective.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Koichi Takiguchi, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

February 18, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/SLCGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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