Tocilizumab with endovascular therapy for acute basilar artery large-vessel occlusion

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-3

This trial tests whether adding the interleukin-6 blocker tocilizumab to endovascular treatment helps adults with acute basilar artery large-vessel occlusion strokes recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Drugs / interventions: tocilizumab
• Locations: 13 sites (Suzhou, Anhui and 12 other locations)
• Trial ID: NCT07509645 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled phase III trial enrolls adults with acute basilar artery large-vessel occlusion who are planned for endovascular therapy within 24 hours. Participants are randomized to receive either tocilizumab or placebo in addition to standard endovascular treatment, with both investigators and patients blinded to allocation. Key inclusion criteria include NIHSS ≥10 and pc-ASPECTS ≥6, while major exclusions include intracranial hemorrhage, pre-stroke disability (mRS >1), known allergies to study agents or contrast, and bleeding disorders. The trial compares clinical outcomes and safety between arms to see if IL-6 blockade improves prognosis after posterior circulation stroke.

Who should consider this trial

Good fit: Adults (≥18) with acute basilar artery large-vessel occlusion who are eligible for endovascular therapy within 24 hours, have NIHSS ≥10 and pc-ASPECTS ≥6, and can provide informed consent or have a legal representative available.

Not a fit: Patients with intracranial hemorrhage, pre-stroke disability (mRS >1), known allergy to tocilizumab or iodinated contrast, active bleeding or bleeding disorders, or those not undergoing basilar artery endovascular treatment are unlikely to benefit.

Why it matters

Potential benefit: If successful, adding tocilizumab could reduce inflammation-related brain injury and improve functional recovery after basilar artery occlusion treated with endovascular therapy.

How similar studies have performed: Targeting IL-6 for neuroprotection in ischemic stroke is relatively novel—there is supportive preclinical evidence and limited early-phase clinical data, but large randomized phase III results are scarce.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older, of either sex;
2. Acute ischemic stroke caused by occlusion of the basilar artery;
3. Decide to undergo emergency endovascular treatment;
4. Time from stroke onset to groin puncture within 24 hours;
5. National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
6. Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6;
7. Signed informed consent from the patients or the legally authorized representatives.

Exclusion Criteria:

1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
2. Pre-stroke modified Rankin scale (mRS) score \>1;
3. Known allergy to tocilizumab or excipients;
4. Known allergy to iodinated contrast agents;
5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
7. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
8. Neutrophils \< 2 × 10\^9 /L;
9. Platelets \< 100 × 10\^9 /L;
10. Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/L (400 mg/dL);
11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal;
12. Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min;
13. Pregnant, lactating, or planning pregnancy within 90 days;
14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
15. Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
16. Presence of autoimmune diseases or use of immunosuppressive drugs;
17. Systemic infectious diseases;
18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
19. Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
20. Other conditions that the investigator considers might affect compliance or preclude participation in this study.

Where this trial is running

Suzhou, Anhui and 12 other locations

• Suzhou Municipal Hospital — Suzhou, Anhui, China (Recruiting)
• Anyang People's Hospital — Anyang, Henan, China (Recruiting)
• Nanyang Central Hospital — Nanyang, Henan, China (Recruiting)
• The First Affiliated Hospital of Henan Medical University — Xinxiang, Henan, China (Recruiting)
• People's Hospital of Xihua — Zhoukou, Henan, China (Recruiting)
• People's Hospital of Linyi — Linyi, Shandong, China (Recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Recruiting)
• Xianyang First People's Hospital — Xianyang, Shanxi, China (Recruiting)
• Yuncheng Central Hospital — Yuncheng, Shanxi, China (Recruiting)
• Lishui Central Hospital — Lishui, Zhejiang, China (Recruiting)
• Taizhou enze Hospital — Taizhou, Zhejiang, China (Recruiting)
• People's Hospital of Yueqing — Yueqing, Zhejiang, China (Recruiting)
• Capital Medical Univercity Xuanwu Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xunming Ji

Conditions Ischemic Stroke; large vessel occlusion; endovascular treatment; posterior circulation; interleukin-6 inhibitor; neuroprotection