\*\*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.
Voluntary participation in the clinical study: fully understands and is informed about the study and has signed the informed consent form in writing; willing to comply with and able to complete all trial procedures.
Age: >=18 years; male or female.
Pathologically confirmed Glioblastoma.
Subtotal resection or recurrent/progressive disease 4-6 weeks after surgery (before radiotherapy).
Currently participating in another clinical study, or less than 4 weeks since completion of treatment in a previous clinical study.
History of malignancy other than Glioblastoma within the past 3 years, or another uncured primary malignancy.
Prior history of brain radiotherapy.
Pregnant or lactating women.
Single group
Sintilimab
DrugSintilimab 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
DrugBevacizumab 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
RadiationPostoperative radiotherapy will be administered as part of concurrent chemoradiotherapy according to the study treatment protocol.
Temozolomide
DrugTemozolomide 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.
Progression Free Survival（PFS）
The time from the start of treatment until tumor progression or death from any cause.
Overall Survival (OS)
Quality of life accessed by EORTC-QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) will be used to assess health-related quality of life. All EORTC QLQ-C30 scores are linearly transformed to a scale ranging from 0 to 100. For the global health status/quality of life scale and functional scales, higher scores indicate better quality of life or better functioning. For symptom scales and single symptom items, higher scores indicate worse symptoms or greater symptom burden.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary safety analysis will be conducted based on subjects who experience toxicity (as defined by CTCAE standards). CTCAE version 5.0 will be used to evaluate safety through reported adverse events.
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