Status:
RECRUITING
Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a prospective Bayesian adaptive randomized phase II clinical trial of enhanced adjuvant therapy for newly diagnosed glioblastoma with partial surgical resection or short-term progression...
Eligibility Criteria
Inclusion
- Voluntary participation in clinical research: fully understand and be informed of this study, and sign a written informed consent form; Willing to follow and capable Complete all experimental procedures.
- Age: ≥ 18 years old, both male and female are acceptable.
- Pathologically diagnosed GBM patients
- Partial surgical resection or recurrence and progression 2-6 weeks after surgery (before radiotherapy)
- Adequate organ and bone marrow function, without severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, or immune deficiency:
- Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 \* 109/L (1500/mm3), platelets ≥ 75 \* 109/L, hemoglobin ≥ 9 g/dL (if bone marrow is involved, platelets ≥ 50 \* 109/L, ANC ≥ 1.0 \* 109/L, hemoglobin ≥ 8 g/dL).
- Liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal value (AST is allowed if there is liver involvement, ALT ≤ 5 times the upper limit of normal value).
- Renal function: Serum creatinine ≤ 1.5 times the upper limit of normal value.
- Coagulation function: INR ≤ 1.5 times the upper limit of normal value; PT and APTT are ≤ 1.5 times the upper limit of normal values (unless the subject is receiving anticoagulant treatment and PT and APTT are within the expected range of anticoagulant treatment at the time of screening).
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- The serum pregnancy test is negative, and effective contraceptive measures have been taken from the signing of the informed consent form until 6 months after the last chemotherapy.
- Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) are all within the normal range of ± 10%.
- Ophthalmic examination: including dilated pupil fundus examination, slit lamp examination, and fundus color photography.
Exclusion
- 1\) Currently participating in other clinical studies, or less than 4 weeks after the end of treatment in the previous clinical study.
- 2\) In the past 3 years, there has been a history of malignant tumors other than GBM, or other primary malignant tumors that have not been cured.
- 3\) Previous history of brain radiation therapy. 4) Pregnant or lactating women. 5) After evaluation, there are patients with contraindications to radiotherapy. 6) Serious active comorbidities that may affect the treatment of this study. 7) Active infections that require systematic anti infective treatment, including but not limited to bacterial, fungal, or viral infections.
- 8\) Patients with heart failure, unstable angina, severe uncontrolled ventricular arrhythmias, acute ischemia or myocardial infarction as determined by the New York Heart Association (NYHA) functional classification within the first 6 months of screening.
- 9\) QTcF interval\>480milliseconds, unless secondary to bundle branch block. 10) Suffering from uncontrollable comorbidities, including but not limited to uncontrolled hypertension, active peptic ulcers, or bleeding disorders.
- 11\) Individuals with a history of mental illness in the past; Individuals without legal capacity or with limited legal capacity.
- 12)Medical history or disease evidence that may interfere with the trial results, hinder the subjects' full participation in the study, abnormal treatment or laboratory test values, or other situations that the researchers consider unsuitable for inclusion.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06936046
Start Date
January 1 2025
End Date
January 1 2027
Last Update
April 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China