Phase III Clinical Trial Evaluating the Efficacy and Safety of 5-aminolevulinic Acid (5-ALA）

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open, parallel-group, multicenter clinical trial evaluating 5-aminolevulinic acid (5-ALA HCl) oral solution with powdered fluorescent microscopic tumor resection versus white light microscopic tumor resection in patients with malignant gliomas (WHO grade 3/4).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• Males or females 18-70 years of age, inclusive;

• Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging;

• have a Karnofsky Performance Status (KPS) ≥ 60;

• Ability to take oral medications;

• Laboratory tests meeting the following criteria within ≤ 7 days preoperatively:

Alanine aminotransferase (ALT), Mentholatum aminotransferase (AST), Glutamyl transpeptidase (GGT) < 100 IU/L; Serum total bilirubin (TBIL) < 51.3 μmol/L (3.0 mg/dl); Serum creatinine (CRE) < 176.8 μmol/L (2.0 mg/dl);

• Non-surgically sterilized or female subjects of childbearing potential need to have a negative serum pregnancy test result and must be non-lactating females; female subjects of childbearing potential and male subjects whose spouses are of childbearing potential are voluntarily using contraception for a period of 3 months after administration of the test drug;

• Subjects are able to understand the informed consent form, voluntarily participate and sign the informed consent form, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria:

• Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs;

• acute or chronic porphyria; history of cutaneous photosensitivity, actinic dermatoses, and exfoliative dermatitis

• Tumor located in the midline, basal ganglia, cerebellum, or brainstem;

• Inability to undergo enhanced MRI (pacemaker, contrast allergy, and other reasons);

• Subjects taking other trial medications within 30 days prior to the start of this trial or subjects undergoing other clinical trials at the same time;

• Comorbid uncontrolled cardiac conditions such as: a) New York Heart Association (NYHA) class ≥II, b) severe/unstable angina, c) primary cardiomyopathy, d) myocardial infarction or previous coronary/peripheral artery bypass grafting within ≤6 months prior to the procedure, e) difficult-to-control hypertension, f) severe arrhythmia requiring medication or intervention, and g) screening echocardiographic left ventricular ejection fraction <50%;

• Active hepatitis B or C (unless HBV-DNA titers below the minimum detection limit and HCV-RNA negative on antiviral therapy can be included), HIV-positive or known history of acquired immunodeficiency syndrome;

• Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;