Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric… (NCT06871527) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer
China44 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, myocar…
What they're measuring
1
Phase Ib: Maximum tolerated dose (MTD)
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
2
Phase Ib: RD
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
3
Six-month progression-free survival
Timeframe: At six months
Trial details
NCT IDNCT06871527
SponsorSixth Affiliated Hospital, Sun Yat-sen University