Predicting the Efficacy in Advanced Gastric Cancer.

City of Hope

Status: Completed

Conditions: Chemotherapy Effect; Gastric Cancer; Paclitaxel; Ramucirumab

Treatments: Drug: Paclitaxel

Study type: Observational

Funder types: Other

Identifiers

NCT06490055

23228/SLCGC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

162 participants in 2 patient groups

Gastric cancer chemotherapy responders received second-line chemotherapy

Description:

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)

Treatment:

Drug: Paclitaxel

Gastric cancer chemotherapy non-responders received second-line chemotherapy

Description:

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)

Treatment:

Drug: Paclitaxel