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

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sintilimab — DRUG
  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.
• Bevacizumab — DRUG
  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.
• Postoperative Radiotherapy — RADIATION
  Postoperative radiotherapy will be administered as part of concurrent chemoradiotherapy according to the study treatment protocol.
• Temozolomide — DRUG
  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.

Study Details

\*\*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.

Key Dates

First listed

Jun 25, 2026

Start date

Dec 1, 2025

Status verified

Dec 2025

Primary completion

Dec 1, 2027

Completion

Dec 1, 2027

Study Design

Enrollment

31 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sintilimab plus Bevacizumab
  For high-risk newly diagnosed glioblastoma patients who undergo partial surgical resection or have short-term recurrent progression 4-6 weeks before radiotherapy after surgery, eligible participants who sign the informed consent form and meet all inclusion and exclusion criteria will receive postoperative concurrent chemoradiotherapy followed by enhanced adjuvant therapy. Concurrent radiotherapy and temozolomide will be administered for approximately 28 days. After completion of concurrent chemoradiotherapy, participants will receive adjuvant temozolomide combined with sintilimab and bevacizumab. Sintilimab 200 mg and bevacizumab 10 mg/kg will be administered by intravenous infusion once every 21 days for up to 1 year.

Primary Outcome Measure

Progression Free Survival（PFS） [ Time Frame: 2 year ]

Central Contacts

• Ting Zhang, Dr.
  86+15157125533
  [email protected]

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