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

Phase 1

Not yet recruiting

• Conditions: Gastric (Stomach) Cancer; Gastric Adenocarcinoma; Fruquintinib; PD-1 Inhibitor; Tislelizumab; GEJ Adenocarcinoma
• Interventions: Drug: fruquintinib + tislelizumab + FOLFOX

• Registration Number: NCT06871527
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Primary Completion: 2028-03-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fruquintinib + tislelizumab + FOLFOX	fruquintinib + tislelizumab + FOLFOX	fruquintinib + tislelizumab + FOLFOX

Primary Outcome Measures

Name	Time	Method
Phase Ib: Maximum tolerated dose (MTD)	At the end of Cycle 1 (each cycle is 21 days)	Maximum Tolerated Dose (MTD) of fruquintinib. Investigators leading the study will find the maximum tolerated dose by assessing the rate of serious side effects (known as "dose limiting toxicities") among participants according to the CTCAE 5.0.
Phase Ib: RD	At the end of Cycle 1 (each cycle is 21 days)	To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
Six-month progression-free survival	At six months	The proportion of patients who remain alive and free from disease progression for at least 6 months after initiating treatment.

Secondary Outcome Measures

Name	Time	Method
OS	Up to 3 years	OS is defined as the time from the date of randomization to the date of death due to any cause.
PFS	Up to 3 years	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
ORR	Up to 3 years	ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) per RESISTv1.1.
DCR	Up to 3 years	DCR is defined as the percentage of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) per RESISTv1.1.

Trial Locations

Locations (1)

The Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China