A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called edaravone dexborneol for people who have had a type of stroke called an acute ischemic stroke, especially those who also have active cancer. The goal is to see if this treatment, which helps protect brain cells by reducing damage from inflammation and harmful molecules, can improve recovery of brain function after a stroke. Researchers will compare this treatment to the usual care to find out if it works better and is safe for patients with both stroke and cancer, who often face more challenges during recovery.

To take part, patients need to be between 18 and 80 years old, have had a recent stroke confirmed by doctors, and have active cancer either diagnosed recently or currently being treated. Participants will receive either the study treatment or standard care and will be closely monitored with regular check-ups and brain scans to track their progress and safety. People with bleeding in the brain, very severe illness, or certain other health conditions won’t be eligible. The results of this study could help doctors find better ways to treat stroke in patients who also have cancer, a group that currently has limited treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 80 years (inclusive); 2. Diagnosis of acute ischemic stroke (AIS) according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke; 3. Time from symptom onset to enrollment ≤48 hours; 4. Presence of focal neurological deficits with a baseline NIHSS score of 4-24, and a combined score of ≥2 points on NIHSS Item 5 (upper limb motor) and Item 6 (lower limb motor); 5. Confirmed active malignancy before stroke onset or during hospitalization, defined as: Cancer diagnosed within 12 months prior to stroke, Presence of metastatic disease, Received cancer-directed therapy within the past 30 days, or Patients who declined cancer treatment (still considered active malignancy); 6. Signed informed consent obtained from the patient or legally authorized representative.
• Exclusion Criteria:
• • Patients meeting any of the following criteria will be excluded: 1. Intracranial hemorrhagic diseases detected on head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; 2. Pre-stroke modified Rankin Scale (mRS) score \>1; 3. Transient ischemic attack (TIA) as the current event; 4. Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies; 5. Use of neuroprotective agents, including but not limited to: marketed edaravone, nimodipine, gangliosides, citicoline, piracetam, butylphthalide, human urinary kallidinogenase, or certain Chinese herbal medicines (see Concomitant Medications for details); 6. Patients with severe psychiatric disorders or dementia; 7.Hepatic or renal dysfunction: ALT or AST \>3× upper limit of normal (ULN); Known liver diseases (e.g., acute/chronic active hepatitis, cirrhosis); Known kidney disease, renal insufficiency, serum creatinine \>1.5×ULN, or creatinine clearance \<50 mL/min; 8.Severe systemic diseases with an expected survival \<90 days; 9. Pre-stroke Eastern Cooperative Oncology Group (ECOG) performance status ≥3; 10. Hypersensitivity to edaravone, (+)-borneol, or any excipients; 11. Pregnancy, lactation, or planned pregnancy; 12. Participation in another clinical trial within 30 days prior to randomization or current enrollment in other interventional studies; 13.Any other condition deemed inappropriate for participation by the investigator.