Clinical trial · Interventional
Microsurgical Resection Combined With Photodynamic Therapy for Recurrent Glioblastoma
Effectiveness and Safety of Microsurgical Resection Combined With Photodynamic Therapy (PDT) Using Hematoporphyrin Injection (Hiporfin) for Recurrent Glioblastoma: A Prospective, Single-Arm, Open-Label, Single-Center Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This single-center, prospective, single-arm, open-label clinical study evaluates the effectiveness and safety of microsurgical resection combined with photodynamic therapy (PDT) in patients with recurrent glioblastoma (GBM). Patients receive intravenous hematoporphyrin injection (Hiporfin) 5 mg/kg 48-72 hours before surgery. Standard craniotomy with microsurgical resection of the recurrent tumor is then performed, followed by intraoperative irradiation of the resection cavity with a 630-nm semiconductor laser (fluence 150-200 J/cm2). The primary outcome is the rate of tumor recurrence within 2 years after surgery. Participants are followed postoperatively for up to 24 months with contrast-enhanced brain MRI, neurological and quality-of-life assessments (EORTC QLQ-C30), and adverse event monitoring.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma (WHO-Grade IV Glioma) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 630-nm Semiconductor Laser | Device | — | UNRESOLVED |
| Hematoporphyrin Injection (Hiporfin) | Drug | — | UNRESOLVED |
| Microsurgical Tumor Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microsurgical Resection + PDT
- description
- Patients receive hematoporphyrin injection (Hiporfin) 5 mg/kg intravenously in 250 mL normal saline under light protection 48-72 hours before surgery, after a negative skin test. Standard craniotomy with microsurgical resection of recurrent glioblastoma is performed, followed by intraoperative irradiation of the resection cavity with a 630-nm semiconductor laser (1 W, 120-150 mW/cm2, 150-200 J/cm2). Dexamethasone 10 mg IV daily for 3 days preoperatively. Postoperative whole-body light protection for 72 hours and avoidance of direct sunlight for 30 days.
- interventionNames
- Drug: Hematoporphyrin Injection (Hiporfin)
- Procedure: Microsurgical Tumor Resection
- Device: 630-nm Semiconductor Laser
Primary outcomes (1)
- measure
- Rate of tumor recurrence or progression within 2 years after surgery
- timeFrame
- 24 months after surgery (brain MRI every 2 months)
- description
- The proportion of participants with radiologically confirmed tumor recurrence or progression on contrast-enhanced brain MRI within 24 months after combined surgery and PDT, assessed according to the radiologic criteria specified in the study protocol (maximum perpendicular diameters of measurable lesions).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-65 years, any sex * KPS score \>= 70 and ECOG performance status 0-2 * Patient and family members willing and able to provide written informed consent * Histopathologically confirmed glioblastoma (WHO grade IV) that has progressed or recurred after standard radiotherapy and chemotherapy, based on radiological evidence of measurable disease * More than 3 months since completion of brain radiotherapy * Hospitalized for recurrence/progression with a sizable lesion causing related symptoms and/or mass effect, for which gross-total or subtotal resection is considered feasible at reoperation * No concomitant malignancy, severe autoimmune disease or congenital immunodeficiency, severe active infection, cranial nerve disorder, or psychiatric disease * Life expectancy greater than 12 weeks * Cardiac function: essentially normal electrocardiogram, stable hemodynamics, left ventricular ejection fraction \> 55% * White blood cell count \> 3.5 x 10\^9/L, platelet count \> 100 x 10\^9/L, absolute neutrophil count \> 1.5 x 10\^9/L, hemoglobin \> 90 g/L * ALT and AST \< 2.5 x upper limit of normal (\< 5 x ULN if hepatic impairment mainly due to tumor infiltration), total bilirubin \< 1.5 x ULN, serum creatinine \< 1 x ULN * INR or prothrombin time \< 1.5 x ULN and APTT \< 1.5 x ULN (for patients on anticoagulation, PT/PTT within the expected therapeutic range) * Negative for HIV antibody, Treponema pallidum antibody, HBsAg, HCV antibody, and EBV-DNA * Female subjects must use effective contraception throughout the study, with negative serum or urine pregnancy test at screening and during the study * Able to attend regular follow-up visits at the study institution throughout the trial * Expected benefit of participation judged to outweigh the risks by the investigators Exclusion Criteria: * KPS score \< 70 * Prior or concurrent malignancy at other sites, unless disease-free for \>= 3 years * Pregnant or lactating women * History of allergy to photosensitizers or hematoporphyrin * Porphyria or soy allergy * Contraindications to surgery * Other uncontrolled active infection * Treatment with any investigational drug within 30 days before study entry * Psychiatric disease or other conditions (e.g., uncontrolled cardiac or pulmonary disease, diabetes) precluding compliance with study treatment and monitoring * Severe renal or hepatic impairment (bilirubin \> 1.5 x ULN, alkaline phosphatase and AST \> 2.5 x ULN, creatinine clearance \< 30 mL/min) * Prior allogeneic tissue or organ transplantation * Poor compliance or inability to follow skin photosensitivity precautions * HIV-positive or AIDS-related disease * Contraindications to magnetic resonance imaging * Follow-up impossible for psychological, family, social, or geographical reasons * Lack of legal capacity (deprived of liberty or under guardianship) * Refusal to participate or to provide consent * Any other condition judged unsuitable for enrollment by the investigator
References
Publications (0)
Data not yet available