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Clinical Trials in China / NCT06871527
Starting soon Phase 1/2

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

NCT06871527 · tracked via the Priya Life Science China tracker
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Phase
Phase 1/2
Started
2025-03-01
Last updated
2025-03-12

Condition(s) studied

Gastric (Stomach) CancerGastric AdenocarcinomaFruquintinibPD-1 InhibitorTislelizumabGEJ Adenocarcinoma

Investigational drug(s) / intervention(s)

fruquintinib + tislelizumab + FOLFOX

fruquintinib + tislelizumab + FOLFOX: phase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W. phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06871527 on ClinicalTrials.gov ↗ ← All trials in China