Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for adults with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma. The study aims to see how safe and effective a combination of three treatments—fruquintinib, a PD-1 inhibitor called tislelizumab, and the chemotherapy regimen FOLFOX—can be when given as the first treatment for patients whose cancer cannot be surgically removed or has spread to other parts of the body.

To participate in this trial, individuals must be between 18 and 75 years old and in relatively good health, with specific criteria related to their cancer diagnosis and overall condition. Participants will need to have at least one measurable area of cancer and must not have received previous treatment for their metastatic disease. The trial is not yet recruiting, but those who qualify will have the chance to receive this new combination therapy while closely monitored for safety and effectiveness. It's important for potential participants to understand the study fully and give their consent before joining.

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Eligibility criteria

• Inclusion Criteria:
• • 18-75 years old (including 18 and 75 years old);
• • Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
• • Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
• • Advanced patients with radiographic confirmation of inoperable complete resection;
• • No previous anti-tumor treatment for metastatic diseases;
• • At least one measurable lesion according to RECIST version 1.1;
• • Ability to take medications orally;
• • No active bleeding;
• * Adequate organ functions:
• • Absolute neutrophil count ≥2×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥4×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；
• • • Have fully understood the study and voluntarily signed the informed consent;
• Exclusion Criteria:
• • Patients who had received any drug in the study protocol in the last year;
• • Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
• • HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;
• • Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
• • Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;
• • Patients with massive pleural or peritoneal effusion requiring drainage;
• • Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;
• • Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
• • Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;
• • Patients with autoimmune diseases;
• • Patients with grade 3 or higher bleeding within 4 weeks;
• • Patients with a history of allergy to any drug, similar drug or vehicle in this study;
• • Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;
• • Patients with nonhealed wounds, ulcers, or fractures;
• • Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;
• • Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;
• • Investigators believe that the patient has any other conditions that are not suitable for participating in the study.