Clinical trial · Interventional
Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence
A Randomized Phase II Trial of Concurrent Low-dose Bevacizumab and HSRT Versus Bevacizumab Alone for Glioblastoma at First Recurrence: HSCK-005
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Hypofractionated Stereotactic Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HSRT+Low-dose Bevacizumab
- description
- HSRT with low-dose bevacizumab every 2 weeks
- interventionNames
- Radiation: Hypofractionated Stereotactic Radiotherapy
- Drug: Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab
- description
- Bevacizumab every 2 weeks
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression-free Survival rate at 6 Months
- timeFrame
- From randomization to six months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-70 years of age; * Karnofsky performance status (KPS) ≥ 60; * Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma; * Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven; * Measurable disease; * Estimated survival of at least 3 months, maximal diameter on T1+C MRI ≤ 3.5 cm; * Hgb \> 9 gm; absolute neutrophil count (ANC) \> 1500/μl; platelets \> 100,000; Creatinine \< 1.5 times the upper limit of laboratory normal value; Bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \< 3 times the upper limit of laboratory normal value; * Signed informed consent form; * Agreed to participate the follow-up. Exclusion Criteria: * Prior invasive malignancy unless disease free; * Received re-irradiation; * More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter; * Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR; * Pregnancy or or nursing mothers; * Participated in other trials after diagnosis of recurrent; * Influence factors toward oral medications; * Patients with CTCAE5.0 grade 3+ bleeding; * Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50%; * Long-term unhealed wounds or fractures; * History of organ transplantation; * Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
References
Publications (2)
- BACKGROUNDGuan Y, Li J, Gong X, Zhu H, Li C, Mei G, Liu X, Pan L, Dai J, Wang Y, Wang E, Liu Y, Wang X. Safety and Efficacy of Hypofractionated Stereotactic Radiotherapy with Anlotinib Targeted Therapy for Glioblastoma at the First Recurrence: A Preliminary Report. Brain Sci. 2022 Apr 2;12(4):471. doi: 10.3390/brainsci12040471. PMID 35448002
- BACKGROUNDGuan Y, Xiong J, Pan M, Shi W, Li J, Zhu H, Gong X, Li C, Mei G, Liu X, Pan L, Dai J, Wang Y, Wang E, Wang X. Safety and efficacy of Hypofractionated stereotactic radiosurgery for high-grade Gliomas at first recurrence: a single-center experience. BMC Cancer. 2021 Feb 5;21(1):123. doi: 10.1186/s12885-021-07856-y. PMID 33546642