Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer

July 9, 2025 updated by: City of Hope Medical Center

Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer

Although advances in chemotherapy have improved the prognosis of gastric cancer patients, many patients still suffer from adverse events. Therefore, it is necessary to establish personalized treatment by identifying patients at high risk for side effects. Although paclitaxel-based therapy is the standard second-line treatment, peripheral neuropathy is a troublesome adverse event. The purpose of this study is to establish a liquid biopsy assay to predict paclitaxel-induced peripheral neuropathy in gastric cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Paclitaxel-based therapy is the standard second-line treatment for gastric cancer patients, but approximately 30-40% of patients develop peripheral neuropathy that interferes with daily life, and about 10% develop severe grade 3 peripheral neuropathy. Particularly severe side effects can cause patients to lose strength, forcing them to discontinue treatment, and thus losing the opportunity to receive other treatments that were originally expected to have a therapeutic effect. This study aims to predict peripheral neuropathy in the side effects of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). If patients at high risk for side effects can be predicted prior to treatment, high-risk patients can be offered drug reductions or other chemotherapy options. The aim of this study is to predict peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer by liquid biopsy.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Okayama
      • Kurashiki, Okayama, Japan, 7010192

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

N/A

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 Gastric cancer (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
Patients with peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer
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
Other Names:
  • Ramucirumab
Patients without peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer
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
Other Names:
  • Ramucirumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peripheral neuropathy
Time Frame: 1 year
The standard approach to treatment-related adverse events that occur during anticancer treatment is the Common Terminology Criteria for Adverse Events (CTCAE), which is maintained by the US National Cancer Institute.
1 year

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 (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

June 16, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/SLCGC-AE

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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