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A Single-Arm Clinical Study Evaluating Low-Dose Bevacizumab Combined with Standard Concurrent Chemoradiotherapy for Newly Diagnosed Glioblastoma with Rapid Early Progression

A Single-Arm Clinical Study Evaluating Low-Dose Bevacizumab Combined with Standard Concurrent Chemoradiotherapy for Newly Diagnosed Glioblastoma with Rapid Early Progression

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123517
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

Single experimental arm:Bevacizumab (BEV) 5 mg/kg, intravenous infusion, once every 3 weeks, for a total of 6 cycles. Temozolomide (TMZ) — Concomitant Phase: 75 mg/m^2/day for 42 consecutive days
Adjuvant Phase: 150–200 mg/m^2/day on Days 1–5, every 28 days for a total of 6 cycles. Radiotherapy (RT): 60 Gy in 30 fractions (2 Gy per fraction), 5 fractions per week, for a total of 6 weeks, using

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–70 years; 2.Histologically confirmed glioblastoma; 3.Newly diagnosed patients; 4.Treated via neurosurgical intervention; 5.Expected to commence chemoradiotherapy 4–6 weeks after surgical resection; 6.Postoperative imaging confirms Rapid Early Progression (REP); 7.ECOG performance status 0–1; 8.Anticipated survival of >=3 months; 9.Normal major organ function.

Exclusion criteria

Exclusion criteria: Absolute Exclusion (4.2.1): 1.Severe infection (requiring hospitalization, bacteremia, or severe pneumonia) within 4 weeks prior to enrollment; 2.Known allergy to bevacizumab or humanized antibodies; 3.Active bleeding or hemorrhagic disease; 4.Unhealed postoperative incision, infection, or cerebrospinal fluid (CSF) leak; 5.Inability to undergo MRI or allergy to MRI contrast agents; 6.Allergy to temozolomide; 7.Participation in another clinical trial or use of other investigational drugs within 30 days prior to enrollment. Relative Exclusion (4.2.2): 1.Uncontrolled hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure > 90 mmHg); 2.Myocardial infarction or unstable angina within the past 6 months; 3.Congestive heart failure (NYHA Class >= II); 4.Severe arrhythmia (excluding asymptomatic atrial fibrillation); 5.Active Hepatitis B or Hepatitis C (HBsAg+ / HBV DNA >= ULN, or HCV-Ab+ / HCV RNA >= ULN); 6.Use of high-dose aspirin (> 325 mg/day) or antiplatelet agents within 14 days prior to the first dose of study medication.

Design outcomes

Primary

MeasureTime frame
6-month progression-free survival rate (PFS-6);

Secondary

MeasureTime frame
Median progression-free survival;Overall Survival (OS);1-year overall survival rate;Objective Response Rate (ORR);Quality of Life Score (Optional);

Countries

China

Contacts

Public ContactHong Jinsheng

The First Affiliated Hospital of Fujian Medical University

hjs703@126.com+86 137 9937 5732

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026