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

NCT ID: NCT06871527

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2028-12-31

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.

Conditions

Gastric (Stomach) Cancer; Gastric Adenocarcinoma; Fruquintinib; PD-1 Inhibitor; Tislelizumab; GEJ Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fruquintinib + tislelizumab + FOLFOX

fruquintinib + tislelizumab + FOLFOX

Group Type: EXPERIMENTAL

fruquintinib + tislelizumab + FOLFOX

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Xiaohui Zhai

Role: CONTACT

zhaixh@mail.sysu.edu.cn

862038285497

Facility Contacts

Xiaohui Zhai

Role: primary

zhaixh@mail.sysu.edu.cn

862038285497

Other Identifiers

2025ZSLYEC-081

Identifier Type: -

Identifier Source: org_study_id