Clinical trial NCT06490055: Predicting the Efficacy in Advanced Gastric Cancer.
Official title: Predicting the Efficacy of Paclitaxel Plus Ramucirumab in Advanced Gastric Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Chemotherapy Effect
Paclitaxel
Ramucirumab
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients need second-line chemotherapy with unresectable or recurrent Gastric cancer.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chemotherapy response
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kurashiki
country: Japan
facility: Kawasaki Medical University
state: Okayama
Study officials:
affiliation: City of Hope Medical Center
name: Koichi Takiguchi, PhD
role: PRINCIPAL_INVESTIGATOR
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