Recurrent Glioblastoma (WHO-Grade IV Glioma)PDT-rGBMNCT07832448
Microsurgical Resection Combined With Photodynamic Therapy for Recurrent Glioblastoma
A study testing Hematoporphyrin Injection (Hiporfin), Microsurgical Tumor Resection and 630-nm Semiconductor Laser in people with Recurrent Glioblastoma (WHO-Grade IV Glioma), run by Yonggao Mou at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Glioblastoma (WHO-Grade IV Glioma)
- What is being tested?
- Hematoporphyrin Injection (Hiporfin), Microsurgical Tumor Resection and 630-nm Semiconductor Laser
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Background:
For recurrent glioblastoma (WHO grade IV), no standard therapy has been established, and the median overall survival after recurrence is 24-44 weeks.
Tumor-targeted photodynamic therapy (PDT) uses a photosensitizer that preferentially accumulates in tumor tissue; activation with 630-nm laser light generates reactive oxygen species that selectively kill residual tumor cells while sparing normal brain.
Design:
Prospective, single-arm, open-label, single-center study (Sun Yat-sen University Cancer Center, Guangzhou, China). Planned sample size: 10 participants.
Treatment:
Dexamethasone 10 mg intravenously once daily for 3 days before surgery. Two days before surgery, patients enter a darkened room and undergo a photosensitizer skin test (scratch test or intradermal test, 0.01 mg/mL). Patients with a negative skin test receive hematoporphyrin injection (Hiporfin, hematoporphyrin derivative, Chongqing Maile Biopharmaceutical Co., Ltd.; 5 mL: 25 mg) at 5 mg/kg diluted in 250 mL normal saline by light-protected intravenous infusion. Forty-eight hours after infusion, standard craniotomy with microsurgical resection of the recurrent tumor is performed, and the resection cavity is irradiated with a 630-nm semiconductor laser (output power 1 W; power density 120-150 mW/cm2; fluence 150-200 J/cm2; approximately 10-20 minutes) using a cylindrical diffuser or flat-cut fiber selected according to the cavity shape. After phototherapy, the wound is closed routinely. Postoperatively, patients remain in a darkened room with whole-body skin protection for 72 hours and avoid direct outdoor sunlight until 30 days after surgery.
Follow-up:
Contrast-enhanced brain MRI at day 3, day 7 (+/-1), day 30 (+/-2), day 90 (+/-2), day 180 (+/-2), day 270 (+/-2), and day 360 (+/-1); thereafter every 2 months (efficacy) and monthly (survival). Neurological examination, Karnofsky/ECOG performance status, EORTC QLQ-C30 quality-of-life assessment, and laboratory safety tests are performed at scheduled visits.
Analysis:
Efficacy and safety analyses will be performed on the per-protocol set. All statistical tests will be two-sided with P <= 0.05 considered significant. Adverse events will be graded according to NCI CTCAE version 5.0 and coded with MedDRA.
- Being tested
- Hematoporphyrin Injection (Hiporfin), Microsurgical Tumor Resection, 630-nm Semiconductor Laser
- Keywords
- Recurrent Glioblastoma, photodynamic therapy, microsurgical resection, survival
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematoporphyrin Injection (Hiporfin)Drug
Also called HpD, Hiporfin
Skin test (scratch or intradermal, 0.01 mg/mL) 2 days before surgery; if negative, hematoporphyrin derivative (HpD) 5 mg/kg in 250 mL normal saline by light-protected intravenous infusion 48-72 hours before surgery.
Microsurgical Tumor ResectionProcedure or surgery
Also called surgery
Standard craniotomy for microsurgical gross-total or subtotal resection of the recurrent glioblastoma, performed 48 hours after photosensitizer infusion.
630-nm Semiconductor LaserDevice
Intraoperative irradiation of the resection cavity with a 630-nm semiconductor laser: output power 1 W, power density 120-150 mW/cm2, energy density 150-200 J/cm2, approximately 10-20 minutes, using cylindrical diffuser or flat-cut fiber according to cavity shape.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgical Resection + PDT | Experimental | 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. Receives: Drug: Hematoporphyrin Injection (Hiporfin); Procedure: Microsurgical Tumor Resection; Device: 630-nm Semiconductor Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tumor recurrence or progression within 2 years after surgery
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).
Measured: 24 months after surgery (brain MRI every 2 months)
Secondary outcomes (4)
Recurrence-free survival (RFS)
Time from surgery to first radiologically documented recurrence or progression
Measured: From date of surgery (Day 0) to first documented recurrence/progression or last follow-up; MRI every 2 months, up to 24 months
Overall survival (OS)
Time from surgery to death from any cause.
Measured: From date of surgery to death from any cause or last follow-up; monthly, up to 24 months
Incidence of adverse events, including skin phototoxicity
Adverse events and serious adverse events graded with NCI CTCAE version 5.0, with specific grading of photosensitivity (skin phototoxicity) reactions occurring during the light-protection period.
Measured: From study drug administration (Day 0) through Day 360 (+/-1) and all subsequent follow-up visits
Change in quality of life (EORTC QLQ-C30)
EORTC QLQ-C30 (V3.0) scores administered at baseline and scheduled postoperative visits; change from baseline reported.
Measured: Baseline (preoperative) through Day 360 (+/-1) and follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start4 Aug 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma (WHO-Grade IV Glioma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonggao Mou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yonggao Mou, Sun Yat-sen University
- Investigators
- Yonggao Mou, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832448
- Sponsor's protocol ID
- B2021-199
- Acronym
- PDT-rGBM
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified raw data and the study protocol will be shared via the RDD (https://www.researchdata.org.cn/) platform after study completion (planned within 6 months after the publication of the results).
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07832448
- Acronym / sponsor ID
- PDT-rGBM / B2021-199
- Keywords
- Recurrent Glioblastoma, photodynamic therapy, microsurgical resection, survival
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yonggao MouUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
For recurrent glioblastoma (WHO grade IV), no standard therapy has been established, and the median overall survival after recurrence is 24-44 weeks.
Tumor-targeted photodynamic therapy (PDT) uses a photosensitizer that preferentially accumulates in tumor tissue; activation with 630-nm laser light generates reactive oxygen species that selectively kill residual tumor cells while sparing normal brain.
Design:
Prospective, single-arm, open-label, single-center study (Sun Yat-sen University Cancer Center, Guangzhou, China). Planned sample size: 10 participants.
Treatment:
Dexamethasone 10 mg intravenously once daily for 3 days before surgery. Two days before surgery, patients enter a darkened room and undergo a photosensitizer skin test (scratch test or intradermal test, 0.01 mg/mL). Patients with a negative skin test receive hematoporphyrin injection (Hiporfin, hematoporphyrin derivative, Chongqing Maile Biopharmaceutical Co., Ltd.; 5 mL: 25 mg) at 5 mg/kg diluted in 250 mL normal saline by light-protected intravenous infusion. Forty-eight hours after infusion, standard craniotomy with microsurgical resection of the recurrent tumor is performed, and the resection cavity is irradiated with a 630-nm semiconductor laser (output power 1 W; power density 120-150 mW/cm2; fluence 150-200 J/cm2; approximately 10-20 minutes) using a cylindrical diffuser or flat-cut fiber selected according to the cavity shape. After phototherapy, the wound is closed routinely. Postoperatively, patients remain in a darkened room with whole-body skin protection for 72 hours and avoid direct outdoor sunlight until 30 days after surgery.
Follow-up:
Contrast-enhanced brain MRI at day 3, day 7 (+/-1), day 30 (+/-2), day 90 (+/-2), day 180 (+/-2), day 270 (+/-2), and day 360 (+/-1); thereafter every 2 months (efficacy) and monthly (survival). Neurological examination, Karnofsky/ECOG performance status, EORTC QLQ-C30 quality-of-life assessment, and laboratory safety tests are performed at scheduled visits.
Analysis:
Efficacy and safety analyses will be performed on the per-protocol set. All statistical tests will be two-sided with P <= 0.05 considered significant. Adverse events will be graded according to NCI CTCAE version 5.0 and coded with MedDRA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microsurgical Resection + PDT | Experimental | Drug: Hematoporphyrin Injection (Hiporfin), Procedure: Microsurgical Tumor Resection, Device: 630-nm Semiconductor LaserPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematoporphyrin Injection (Hiporfin)Also: HpD, HiporfinSkin test (scratch or intradermal, 0.01 mg/mL) 2 days before surgery; if negative, hematoporphyrin derivative (HpD) 5 mg/kg in 250 mL normal saline by light-protected intravenous infusion 48-72 hours before surgery. | Drug | Microsurgical Resection + PDT |
| Microsurgical Tumor ResectionAlso: surgeryStandard craniotomy for microsurgical gross-total or subtotal resection of the recurrent glioblastoma, performed 48 hours after photosensitizer infusion. | Procedure or surgery | Microsurgical Resection + PDT |
| 630-nm Semiconductor LaserIntraoperative irradiation of the resection cavity with a 630-nm semiconductor laser: output power 1 W, power density 120-150 mW/cm2, energy density 150-200 J/cm2, approximately 10-20 minutes, using cylindrical diffuser or flat-cut fiber according to cavity shape. | Device | Microsurgical Resection + PDT |
Primary outcome
Rate of tumor recurrence or progression within 2 years after surgery
Time frame: 24 months after surgery (brain MRI every 2 months)
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).
4 secondary outcomes
Recurrence-free survival (RFS)
Time frame: From date of surgery (Day 0) to first documented recurrence/progression or last follow-up; MRI every 2 months, up to 24 months
Overall survival (OS)
Time frame: From date of surgery to death from any cause or last follow-up; monthly, up to 24 months
Incidence of adverse events, including skin phototoxicity
Time frame: From study drug administration (Day 0) through Day 360 (+/-1) and all subsequent follow-up visits
Change in quality of life (EORTC QLQ-C30)
Time frame: Baseline (preoperative) through Day 360 (+/-1) and follow-up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified raw data and the study protocol will be shared via the RDD (https://www.researchdata.org.cn/) platform after study completion (planned within 6 months after the publication of the results).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonggao Mou, Ph.D principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematoporphyrin Injection (Hiporfin), Microsurgical Tumor Resection and 630-nm Semiconductor Laser in people with Recurrent Glioblastoma (WHO-Grade IV Glioma), run by Yonggao Mou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of tumor recurrence or progression within 2 years after surgery (time frame: 24 months after surgery (brain MRI every 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.