Intensified adjuvant therapy for high-risk glioblastoma after partial removal or early progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial enrolls adults with newly diagnosed glioblastoma who have had subtotal tumor resection or early progression before radiotherapy. Participants receive postoperative radiotherapy with concurrent temozolomide, plus additional systemic therapies (sintilimab and bevacizumab) as part of intensified adjuvant treatment. The study aims to determine if this approach can extend progression-free survival and overall survival, monitor safety and adverse events, assess radiation necrosis rates, and evaluate quality of life. Key eligibility requires confirmed glioblastoma, adequate organ function, and absence of significant comorbidities. The trial is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine, and is conducted at a single center in Hangzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).
* Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency:

  1. Complete blood count: absolute neutrophil count (ANC) \>=1.5\*10\^9/L (1500/mm3), platelets \>=75\*10\^9/L, hemoglobin \>=9 g/dL (if there is bone marrow involvement, platelets \>=50\*10\^9/L, ANC \>=1.0\*10\^9/L, hemoglobin \>=8 g/dL).
  2. Liver function: serum bilirubin \<=1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=1.5 times ULN (if there is liver involvement, AST and ALT \<=5 times ULN are allowed).
  3. Renal function: serum creatinine \<=1.5 times ULN.
  4. Coagulation function: INR \<=1.5 times ULN; PT and APTT \<=1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT at screening are within the expected range for anticoagulant therapy).
* Left ventricular ejection fraction (LVEF) \>=50% on cardiac function examination.
* Negative serum pregnancy test, and effective contraceptive measures from signing the informed consent form until 6 months after the last chemotherapy.
* Thyroid-stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) within the normal range ±10%.
* Ophthalmologic examination: including dilated fundus examination, slit-lamp examination, and color fundus photography.

Exclusion Criteria:

* 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.
* Patients assessed as having contraindications to radiotherapy.
* Severe active comorbidity that would affect the study treatment.
* Active infection requiring systemic anti-infective treatment, including but not limited to bacterial, fungal, or viral infection.
* Within 6 months before screening, New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe poorly controlled ventricular arrhythmia, or electrocardiographic evidence of acute ischemia or myocardial infarction.
* QTcF interval \>480 msec, unless secondary to bundle branch block.
* Uncontrolled concomitant disease, including but not limited to uncontrolled hypertension, active peptic ulcer disease, or hemorrhagic disease.
* Prior history of mental illness; lack of capacity for civil conduct or limited capacity for civil conduct.
* Any medical history or disease evidence, treatment, or abnormal laboratory value that may interfere with trial results or prevent the subject from fully participating in the study, or any other condition that the investigator considers unsuitable for enrollment.

Where it's running

• The Second Affiliated Hospital,School of Medicine,Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Zhang, Dr.
• Email: zezht@zju.edu.cn
• Phone: 86+15157125533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.