Predicting the Efficacy in Advanced Gastric Cancer.

NCT06490055 | Completed DMC

• 1 other identifier: 23228/SLCGC
• Study Type: observational
• Target: 162
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Gastric Cancer; Chemotherapy Effect; Paclitaxel; Ramucirumab

Outcome Measures

Primary Outcomes (1)

• Chemotherapy response

  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

Study Arms (2)

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 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

Interventions

Paclitaxel DRUG

Gastric cancer second-line Chemotherapy (paclitaxel plus ramucirumab)

Also known as: Ramucirumab

Gastric cancer chemotherapy non-responders received second-line chemotherapy; Gastric cancer chemotherapy responders received second-line chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (2)

Department of Molecular Diagnostics and Experimental Therapeutics

Monrovia, California, 91016, United States

Location

Kawasaki Medical University

Kurashiki, Okayama-ken, 7010192, Japan

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample before second-line chemotherapy

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Ramucirumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Koichi Takiguchi, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2018
• Primary Completion: February 18, 2025
• Study Completion: July 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

JP (1); US (1)