The efficacy and safety of the bevacizumab in high-risk neuroblastoma

The efficacy and safety of the addition of bevacizumab to conventional induction chemotherapy in high-risk neuroblastoma-: a multicentric randomized controlled phase-3 trial (BRAVEN Trial) - BRAVEN Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074065

Enrollment

162

Registered

2024-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site

Interventions

Intervention1: Bevacizumab arm: This group of patients will receive bevacizumab every two weekly for a total of six doses in addition to conventional induction chemotherapy. The conventional chemother

Eligibility

Inclusion criteria

Inclusion criteria: Children of <=18 years of age with newly diagnosed high-risk neuroblastoma (HR-NB) will be invited to participate after informed consent

Exclusion criteria

Exclusion criteria: 1. Relapsed cases of neuroblastoma 2. Patients with severe organ dysfunction 3. Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection 4. Prior anti-tumor treatment 5. Previous malignant tumours

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy (O) of the addition of bevacizumab (I) to conventional induction chemotherapy in high-risk neuroblastoma patients (P) compared to conventional induction chemotherapy alone (C)Timepoint: 3-month	—

Secondary

Measure	Time frame
To investigate the toxicity profile (O) of the bevacizumab addition to the conventional induction chemotherapy (I) compared to induction chemotherapy alone (C) in high-risk neuroblastoma patients (P).Timepoint: 3-month;To compare the minimal residual disease in blood and bone marrow at the end of induction, both groupsTimepoint: 3-month	—

Countries

India

Contacts

Public ContactDr Jagdish Prasad Meena

All India Institute of Medical sciences, New Delhi

drjpmeena@gmail.com8890139358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026