Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Criteria

Inclusion Criteria:

• Pathologically determined unresectable advanced gastric or gastroesophageal junction adenocarcinoma;

• 18-75 years old (including 18 and 75 years old);

• No previous anti-tumor treatment for metastatic diseases;

• HER2 negative;

• Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;

• Life expectancy ≥ 3 months;

• At least one measurable lesion according to RECIST version 1.1;

• Adequate organ and bone marrow functions:

Absolute neutrophil count≥1.5x10^9/L; Platelet count≥100x10^9/L; Hemoglobin≥9g/dL; Serum bilirubin≤1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤1.5x ULN; Serum creatinine≤1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;

• Women of childbearing age need to take effective contraceptive measures.

Exclusion Criteria:

• Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;

• Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;

• There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;

• Patients with autoimmune diseases or history of autoimmune diseases within 4 weeks before enrollment;

• Previously received allogeneic bone marrow transplantation or organ transplantation;

• Uncontrolled malignant ascites;

• Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;

• Cardiovascular disease, including unstable angina or myocardial infarction, occurred within 6 months before the start of study treatment;

• Subjects allergic to the study drug or any of its adjuvants;

• International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN；

• The researchers judged clinically significant electrolyte abnormalities;

• At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;

• Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);

• Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;

• Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication;

• Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months;

• Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment;

• Ventricular arrhythmia requiring drug treatment;

• Congestive heart failure ≤New York Heart Association (NYHA) class 2;

• LVEF < 50%;

• Active or uncontrolled severe infection ≥ grade 2 according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;

• With positive urine protein and 24-hour urinary protein content>1g;

• Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis;

• Pregnant (positive pregnancy test before medication) or lactating women;

• Complications require long-term immunosuppressive treatment, or systemic or local use of immunosuppressive corticosteroids (> 10mg / day prednisone or other therapeutic hormones);

• By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.