GlioblastomaSTRONGNCT06964815
Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients
A study testing Silibinin as STAT3 inhibitor in people with Glioblastoma and IDH Wild-type and STAT3-positive Glioblastoma, run by Istituto Oncologico Veneto IRCCS at 16 sites in Italy.
Trial summary
Multicenter, double-blind, placebo-controlled, randomized trial. Patients affected by STAT3 positive newly diagnosed glioblastoma will be eligible. Patients are randomized using a stratified block randomization method with a 1:1 ratio in two arms: Experimental/Control arm: Concomitant radiotherapy (60 gy in 30… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma, IDH Wild-type and STAT3-positive Glioblastoma
- What is being tested?
- Silibinin as STAT3 inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 16 sitesItaly
- Study dates
- 12 Nov 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New histologically confirmed diagnosis of glioblastoma (WHO 2021)
- Local availability of MGMT methylation status
- Immunohistochemical positivity of activated STAT3 (pSTAT3) expression on the tumor tissue sample. STAT3 expression will be evaluated centrally by UOC Anatomia Patologica of Azienda Ospedale Università di Padova.
- Chemoradiotherapy start within 7 weeks from surgery
- Patients without disease progression after surgery
- Availability of paraffin-embedded tumor tissue
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- Age ≥18 years
- ECOG PS 0-2; Karnofsky 100-70
- Signing of informed consent prior to any study procedure
- Patients (both males and females) should employ adequate contraceptive measures, which should be maintained during the whole duration of the trial (from screening to 6 months after the last dose of Temozolomide).
- Have adequate bone marrow, liver and kidney function, as measured by the following laboratory assessments conducted within 10 days before the start of study treatment:
- Hemoglobin > 9.0 g/dl
- Absolute neutrophil count (ANC) ≥1500/mm3 without granulocyte colony-stimulating factor (G-CSF) and other hematopoietic growth factors
- Platelet count ≥100,000/μl
- WBC ≥3.0 x 10 9 /L
- Total bilirubin <1.5 times the upper limit of normal
- ALT and AST <3 x the upper limit of normal
- Serum creatinine <1.5 times the upper limit of normal
- Glomerular filtration rate ≥ 30 mL/min/1.73 m2 according to the abbreviated formula Modified Diet in Renal Disease
- Alkaline phosphatase <2.5 x ULN
- PT-INR/PTT <1.5 x upper limit of normal (patients who are therapeutically anticoagulated with anticoagulant drugs will be able to participate provided there is no history of abnormal background in these parameters, based on history).
- Complete urinalysis
- Stable and decreasing corticosteroid dosage in the last 10 days before brain MRI
Who cannot join
- Patients diagnosed with glioblastoma (WHO grade IV 2021) who have only had a diagnostic biopsy
- Chemotherapy, immunotherapy, or antineoplastic therapy for glioblastoma
- Negative immunohistochemistry of STAT3 expression on the tumor tissue sample
- Diagnosis of another tumor or secondary brain localization
- In the investigator's judgment, any evidence of severe or uncontrolled systemic disease including: uncontrolled hypertension; hemorrhagic diathesis; active infection with HBV, HCV, HIV. Screening for such chronic conditions is not required by the protocol; bone marrow reserve or organ dysfunction as demonstrated by laboratory tests.
- Patients who are unable to comply with study procedures and requirements.
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- Contraindication to Brain MRI
- Pregnant or breastfeeding patients
- Patients who are unable to swallow capsules or sachets dissolved in water.
- Patient unable to sign the Informed Consent
- Glioblastoma leptomeningeal dissemination
- Congestive heart failure classified as New York Heart Association (NYHA) Class 2 or higher; Unstable angina (symptoms of angina at rest) or new onset angina ≤3 months prior to screening; myocardial infarction <6 months prior to 'start of study treatment; cardiac arrhythmias requiring antiarrhythmic therapy, with the exception of beta-blockers or digoxin; uncontrolled hypertension (systolic blood pressure [SBP]>140 mmHg or diastolic blood pressure [DBP] >90 mmHg) despite optimal medical management.
- Arterial thrombotic or embolic events such as stroke and/or transient ischemic attacks) or
- Pulmonary embolism in the 6 months prior to the start of study treatment
- Ongoing infection with grade 2 or higher severity (NCI-CTCAE v 5.0)
- Known history of human immunodeficiency virus (HIV) infection; hepatitis B or C active or chronic requiring treatment with antiviral therapy
- History of organ allotransplantation
- Evidence or history of any bleeding diathesis (including mild hemophilia), regardless of its severity;
- Injuries, ulcers or bone fractures that have not fully resolved.
- Renal failure requiring hemodialysis or peritoneal dialysis
- Presenting interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained.
- Persistent proteinuria >3.5 g/24 hours as measured by urinary protein-creatinine ratio from a urine sample (≥ Grade 3, NCI-CTCAE v 5.0). CTCAE 5.0 is also available in Appendix 1.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Italy16 sites
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, BO, 40139
ARNAS G.Brotzu P.O Armando Businco
Cagliari, Italy/Cagliari, 09047
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco "
Catania, Italia/Catania, 95123
Azienda Ospedaliera Universitaria - Careggi
Florence, Italia/FI, 50134
Policlinico San Martino - Genova
Genova
Ospedale A. Manzoni Lecco
Lecco, 23900
USL Nord Ovest Toscana - Livorno
Livorno, Italy/Livorno, 57124
IRST Dino Amadori
Meldola, FC, 47014
Azienda Ospedaliera Universitaria G.Martino
Messina, ME, 98124
Humanitas Cancer Center
Milan, 20089
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, 20157
Ospedale del Mare, ASL Napoli1 Centro
Naples, italy/Napoli, 80147
Istituto Oncologico Veneto
Padova, Italy/Padova, 35128
Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Fondazione Mondino
Pavia, Italy/Pavia, 27100
Istituto Tumori Regina Elena IRCCS
Roma, RM, 00128
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM
About this study
Official title: Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients: a Multicenter, Double-blind, Placebo-controlled, Randomized Study
Multicenter, double-blind, placebo-controlled, randomized trial.
Patients affected by STAT3 positive newly diagnosed glioblastoma will be eligible. Patients are randomized using a stratified block randomization method with a 1:1 ratio in two arms:
Read more
- Experimental/Control arm: Concomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + silibinin/placebo 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + silibinin/placebo 2 sachets/day dissolved in water, day 1-28, q28d for 6-12 cycles. Silibinin/Placebo may be continued until disease progression at the discretion of the physician.
Patients will be stratified based on:
- Type of surgery (complete Vs partial)
- MGMT methylation status (methylated Vs non-methylated)
- ECOG PS (0-1 Vs 2)
- Being tested
- Silibinin as STAT3 inhibitor, Placebo
- Keywords
- Glioblastoma, IDH wild-type and STAT3-positive glioblastoma, silibinin, temozolomide, placebo
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silibinin as STAT3 inhibitorDietary supplement
Sillbrain will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Each 3.7 g sachet of Sillbrain contains 500 mg silibinin. Every patient will assume 2 sachets/day for a total of 1 g/day of silibinin.
PlaceboOther
Placebo will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Every patient will assume 2 sachets/day for a total of 1 g/day of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Silbrain_Experimental Arm | Experimental | Concomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + silibinin 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + silibinin 2 sachets/day dissolved in water, day 1-28, q28d for 6cycles. Silibinin will be continued until disease progression or up to 24 months. In patients who develop progression during temozolomide treatment, administration of silibinin will be continued for up to 6 months after the last dose of temozolomide. Receives: Dietary Supplement: Silibinin as STAT3 inhibitor |
| Placebo_Control Arm | Placebo comparator | Concomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + placebo 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + placebo 2 sachets/day dissolved in water, day 1-28, q28d for 6 cycles. Silibinin/Placebo may be continued until disease progression at the discretion of the physician. Silibinin/Placebo will be continued until disease progression or up to 24 months. In patients who develop progression during temozolomide treatment, administration of silibinin (or placebo) will be continued for up to 6 months after the last dose of temozolomide. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Evaluation of Progression Free Survival (PFS) in patients with newly diagnosed IDH wild-type and STAT3-positive glioblastoma using silibinin 2 sachets per day (1g/day), during chemoradiotherapy and maintenance treatment with temozolomide, compared with placebo. The progression free survival (PFS) will be determined as the time from the date of randomization to the date of disease progression determined using RANO 2.0 criteria or to the date of death, whichever occurs first. Patients without a PFS event at the time of analysis will be censored at the date of last assessment.
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
Liver Toxicity
Evaluation of liver toxicity. Assessment of liver toxicity will be derived from the assay of alanine aminotransferase (ALT) weekly during concomitant radio-chemotherapy treatment and monthly during maintenance temozolomide treatment, using the CTCAE v5.0 system to determine the degree of toxicity
Measured: Through study completion, an average of 2 years
Liver Toxicity
Evaluation of liver toxicity. Assessment of liver toxicity will be derived from the assay of total and direct blood bilirubin weekly during concomitant radio-chemotherapy treatment and monthly during maintenance temozolomide treatment, using the CTCAE v5.0 system to determine the degree of toxicity
Measured: Through study completion, an average of 2 years
Liver Toxicity
Evaluation of liver toxicity. Assessment of liver toxicity will be derived from the assay of aspartate aminotransferase (AST) weekly during concomitant radio-chemotherapy treatment and monthly during maintenance temozolomide treatment, using the CTCAE v5.0 system to determine the degree of toxicity
Measured: Through study completion, an average of 2 years
6/9-months Progression Free Survival (6/9m-PFS)
Evaluation of 6/9-months Progression Free Survival (6/9m-PFS). The progression free survival at 6/9 months (6/9m-PFS) will be determined as the percentage of patient with progression of disease at 6 and 9 months
Measured: Through study completion, an average of 2 years
Objective Response Rate (ORR)
Evaluation of Objective Response Rate (ORR). The objective response rate (ORR) will be defined as the percentage of patients with complete response (CR) and partial response (PR) determined using modified RANO criteria
Measured: Through study completion, an average of 2 years
EORTC QLQ-C30_Quality of Life
Evaluation of Quality of Life assessed by EORTC QLQ-C30. EORTC QLQ-C30 has robust psychometric properties resulting from their use in several international cancer clinical trials. The EORTC QLQ-C30 (Aaronson et al, 1988) is a core measure designed to be supplemented with the disease specific module.
Measured: Through study completion, an average of 2 years
QLQ-BN20_Quality of Life
Evaluation of Quality of Life assessed by QLQ-BN20. QLQBN20 has robust psychometric properties resulting from their use in several international cancer clinical trials.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start12 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: It was noted that, from a methodological standpoint, it would be advisable to use a drug with a marketing authorization (MA) in order to more appropriately assess the treatment's efficacy, which is the study's primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964815
- Sponsor's protocol ID
- IOV-GB-01-2024-STRONG
- Acronym
- STRONG
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients: a Multicenter, Double-blind, Placebo-controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT06964815
- Acronym / sponsor ID
- STRONG / IOV-GB-01-2024-STRONG
- Keywords
- Glioblastoma, IDH wild-type and STAT3-positive glioblastoma, silibinin, temozolomide, placebo
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was noted that, from a methodological standpoint, it would be advisable to use a drug with a marketing authorization (MA) in order to more appropriately assess the treatment's efficacy, which is the study's primary endpoint.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 May 2025 (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.
Multicenter, double-blind, placebo-controlled, randomized trial.
Patients affected by STAT3 positive newly diagnosed glioblastoma will be eligible. Patients are randomized using a stratified block randomization method with a 1:1 ratio in two arms:
- Experimental/Control arm: Concomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + silibinin/placebo 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + silibinin/placebo 2 sachets/day dissolved in water, day 1-28, q28d for 6-12 cycles. Silibinin/Placebo may be continued until disease progression at the discretion of the physician.
Patients will be stratified based on:
- Type of surgery (complete Vs partial)
- MGMT methylation status (methylated Vs non-methylated)
- ECOG PS (0-1 Vs 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silbrain_Experimental Arm | Experimental | Dietary Supplement: Silibinin as STAT3 inhibitorConcomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + silibinin 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + silibinin 2 sachets/day dissolved in water, day 1-28, q28d for 6cycles. Silibinin will be continued until disease progression or up to 24 months. In patients who develop progression during temozolomide treatment, administration of silibinin will be continued for up to 6 months after the last dose of temozolomide. |
| Placebo_Control Arm | Placebo comparator | Other: PlaceboConcomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + placebo 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + placebo 2 sachets/day dissolved in water, day 1-28, q28d for 6 cycles. Silibinin/Placebo may be continued until disease progression at the discretion of the physician. Silibinin/Placebo will be continued until disease progression or up to 24 months. In patients who develop progression during temozolomide treatment, administration of silibinin (or placebo) will be continued for up to 6 months after the last dose of temozolomide. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- New histologically confirmed diagnosis of glioblastoma (WHO 2021)
- Local availability of MGMT methylation status
- Immunohistochemical positivity of activated STAT3 (pSTAT3) expression on the tumor tissue sample. STAT3 expression will be evaluated centrally by UOC Anatomia Patologica of Azienda Ospedale Università di Padova.
- Chemoradiotherapy start within 7 weeks from surgery
- Patients without disease progression after surgery
Key exclusion criteria (22 listed)
- Patients diagnosed with glioblastoma (WHO grade IV 2021) who have only had a diagnostic biopsy
- Chemotherapy, immunotherapy, or antineoplastic therapy for glioblastoma
- Negative immunohistochemistry of STAT3 expression on the tumor tissue sample
- Diagnosis of another tumor or secondary brain localization
- In the investigator's judgment, any evidence of severe or uncontrolled systemic disease including: uncontrolled hypertension; hemorrhagic diathesis; active infection with HBV, HCV, HIV. Screening for such chronic conditions is not required by the protocol; bone marrow reserve or organ dysfunction as demonstrated by laboratory tests.
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 |
|---|---|---|
| Silibinin as STAT3 inhibitorSillbrain will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Each 3.7 g sachet of Sillbrain contains 500 mg silibinin. Every patient will assume 2 sachets/day for a total of 1 g/day of silibinin. | Dietary supplement | Silbrain_Experimental Arm |
| PlaceboPlacebo will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Every patient will assume 2 sachets/day for a total of 1 g/day of placebo. | Other | Placebo_Control Arm |
Primary outcome
Progression Free Survival (PFS)
Time frame: Through study completion, an average of 2 years
Evaluation of Progression Free Survival (PFS) in patients with newly diagnosed IDH wild-type and STAT3-positive glioblastoma using silibinin 2 sachets per day (1g/day), during chemoradiotherapy and maintenance treatment with temozolomide, compared with placebo. The progression free survival (PFS) will be determined as the time from the date of randomization to the date of disease progression determined using RANO 2.0 criteria or to the date of death, whichever occurs first. Patients without a PFS event at the time of analysis will be censored at the date of last assessment.
7 secondary outcomes
Liver Toxicity
Time frame: Through study completion, an average of 2 years
Liver Toxicity
Time frame: Through study completion, an average of 2 years
Liver Toxicity
Time frame: Through study completion, an average of 2 years
6/9-months Progression Free Survival (6/9m-PFS)
Time frame: Through study completion, an average of 2 years
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 years
EORTC QLQ-C30_Quality of Life
Time frame: Through study completion, an average of 2 years
QLQ-BN20_Quality of Life
Time frame: Through study completion, an average of 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silibinin as STAT3 inhibitor in people with Glioblastoma and IDH Wild-type and STAT3-positive Glioblastoma, run by Istituto Oncologico Veneto IRCCS at 16 sites in Italy.
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 23 inclusion and 22 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: withdrawn, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression Free Survival (PFS) (time frame: Through study completion, an average of 2 years). 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 2 Oct 2026.