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

NCT07670026 | Recruiting Phase 2 DMC

• 1 other identifier: Y2025-1805
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival（PFS）

  The time from the start of treatment until tumor progression or death from any cause.

  2 year

Secondary Outcomes (3)

• Overall Survival (OS)

  2 year

• Quality of life accessed by EORTC-QLQ-C30

  2 year

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  2 years

Study Arms (1)

Sintilimab plus Bevacizumab

EXPERIMENTAL

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.

Drug: Sintilimab; Drug: Bevacizumab; Radiation: Postoperative Radiotherapy; Drug: Temozolomide

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.

Sintilimab plus Bevacizumab

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.

Sintilimab plus Bevacizumab

Postoperative Radiotherapy RADIATION

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

Sintilimab plus Bevacizumab

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.

Sintilimab plus Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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).
• Renal function: serum creatinine \<=1.5 times ULN.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital,School of Medicine,Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

sintilimab; Bevacizumab; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ting Zhang, Dr.

CONTACT

86+15157125533; zezht@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 25, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2025-12

Locations

CN (1)