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

Sun Yat-sen University

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

PD-1 Inhibitor

Tislelizumab

Fruquintinib

GEJ Adenocarcinoma

Gastric Adenocarcinoma

Gastric (Stomach) Cancer

Treatments

Drug: fruquintinib + tislelizumab + FOLFOX

Study type

Interventional

Funder types

Other

Identifiers

NCT06871527

2025ZSLYEC-081

Details and patient eligibility

About

This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.