Brief Summary

This is an investigator-initiated phase III clinical trial employing a randomized, double-blind, placebo-controlled design. The primary objective of this study is to investigate the efficacy and safety of an interleukin-6 inhibitor (tocilizumab) combined with endovascular therapy in patients with acute posterior circulation large-vessel occlusion stroke.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

348

participants targeted

Target at P50-P75 for phase_3

Timeline

10mo left

Started Apr 2026

Shorter than P25 for phase_3

Geographic Reach

1 country

13 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

Study Progress15%

Apr 2026Apr 2027

First Submitted

Initial submission to the registry

March 27, 2026

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed

19 days until next milestone

Study Start

First participant enrolled

April 22, 2026

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

March 27, 2026

Last Update Submit

April 29, 2026

Conditions

Ischemic Stroke

Keywords

large vessel occlusionendovascular treatmentposterior circulationinterleukin-6 inhibitorneuroprotection

Outcome Measures

Primary Outcomes (1)

Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days.
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days

Secondary Outcomes (8)

mRS score distribution at 90 days;
90 days
Early neurological improvement at 24 hours
24 hours
NIHSS score at 7 days or at early discharge
7 days
Proportion of patients with mRS score 0-1 at 90 days
90 days
Proportion of patients with mRS score 0-2 at 90 days
90 days
+3 more secondary outcomes

Other Outcomes (4)

Incidence of symptomatic intracranial hemorrhage within 24 hours
24 hours
Incidence of any intracranial hemorrhage within 24 hours
24 hours
Proportion of patients with pneumonia at 7 days or at early discharge
7 days
+1 more other outcomes

Study Arms (2)

Tocilizumab

EXPERIMENTAL

Endovascular treatment combined with a 240mg tocilizumab injection once

Drug: Tocilizumab

Placebo

PLACEBO COMPARATOR

Endovascular treatment combined with placebo

Drug: Placebo

Interventions

TocilizumabDRUG

240 mg of tocilizumab injection will be diluted in 0.9% NaCl to a total volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization and no later than 30 minutes, with an infusion duration of more than 1 hour.

Tocilizumab

PlaceboDRUG

An equivalent volume of placebo will be diluted in 0.9% NaCl to a total volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization and no later than 30 minutes, with an infusion duration of more than 1 hour.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
Pre-stroke modified Rankin scale (mRS) score \>1;
Known allergy to tocilizumab or excipients;
Known allergy to iodinated contrast agents;
Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
Neutrophils \< 2 × 10\^9 /L;
Platelets \< 100 × 10\^9 /L;
Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/L (400 mg/dL);
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal;
Known recent or current serum creatinine \>2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \<60 mL/min;
Pregnant, lactating, or planning pregnancy within 90 days;
Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Capital Medical Universitylead

Study Sites (13)

Suzhou Municipal Hospital

Suzhou, Anhui, 234000, China

RECRUITING

Anyang People's Hospital

Anyang, Henan, 455000, China

RECRUITING

Nanyang Central Hospital

Nanyang, Henan, 473000, China

RECRUITING

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, 453000, China

RECRUITING

People's Hospital of Xihua

Zhoukou, Henan, 466600, China

RECRUITING

People's Hospital of Linyi

Linyi, Shandong, 276000, China

RECRUITING

Zibo Central Hospital

Zibo, Shandong, 255000, China

RECRUITING

Xianyang First People's Hospital

Xianyang, Shanxi, 712000, China

RECRUITING

Yuncheng Central Hospital

Yuncheng, Shanxi, 044000, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

RECRUITING

Taizhou enze Hospital

Taizhou, Zhejiang, 318000, China

RECRUITING

People's Hospital of Yueqing

Yueqing, Zhejiang, 325600, China

RECRUITING

Capital Medical Univercity Xuanwu Hospital

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xunming Ji

CONTACT

01083198962 jixm@ccmu.edu.cn

Chuanjie Wu

CONTACT

01083199439 wuchuanjie@ccmu.edu.cn

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Neurology, Capital Medical University Xuanwu Hospital

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 3, 2026

Study Start

April 22, 2026

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

April 20, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing: Will share

Locations

CN(13)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (4)

Study Arms (2)

Tocilizumab

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations