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Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression

NCT07670026 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-06-25

No results posted yet for this study

Summary

\*\*Brief Summary\*\*

The goal of this clinical trial is to learn whether intensified adjuvant treatment is safe and may help delay disease progression in adults with high-risk newly diagnosed glioblastoma. High-risk newly diagnosed glioblastoma in this study includes glioblastoma that has been partially removed by surgery or glioblastoma that shows early progression or recurrence before postoperative radiotherapy.

The main questions this study aims to answer are:

* Does intensified adjuvant treatment improve median progression-free survival in participants with high-risk newly diagnosed glioblastoma?
* How long do participants survive after receiving this treatment?
* What medical problems do participants have during or after intensified adjuvant treatment?
* How often do participants develop radiation necrosis?
* How does this treatment affect participants' quality of life?

Participants will:

* Receive postoperative concurrent radiotherapy and temozolomide chemotherapy.
* Receive a higher radiation dose to the residual tumor or early recurrent/progressive lesion, while standard radiation doses are given to the tumor bed and surrounding high-risk and low-risk areas.
* Receive adjuvant temozolomide after concurrent chemoradiotherapy.
* Receive sintilimab and bevacizumab by intravenous infusion once every 21 days for up to 1 year.
* Have regular blood tests, biochemical tests, thyroid function tests, myocardial enzyme tests, electrocardiograms, and other safety assessments.
* Have enhanced brain MRI scans regularly to evaluate disease status.
* Be followed by clinic visits and/or telephone calls to collect information about disease progression, survival, side effects, later cancer treatments, and quality of life.

Conditions

Interventions

DRUG

Sintilimab

Sintilimab 200 mg will be administered by intravenous infusion once every 21 days for up to 1 year as part of enhanced adjuvant therapy after completion of concurrent chemoradiotherapy.

DRUG

Bevacizumab

Bevacizumab 10 mg/kg will be administered by intravenous infusion once every 21 days for up to 1 year as part of enhanced adjuvant therapy after completion of concurrent chemoradiotherapy.

RADIATION

Postoperative Radiotherapy

Postoperative radiotherapy will be administered as part of concurrent chemoradiotherapy according to the study treatment protocol.

DRUG

Temozolomide

Temozolomide will be administered concurrently with postoperative radiotherapy for approximately 28 days, followed by adjuvant temozolomide in combination with sintilimab and bevacizumab according to the study treatment protocol.

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670026 on ClinicalTrials.gov