Status:
RECRUITING
The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of low-dose radiotherapy combined with programmed death 1 (PD-1) inhibitor (sintilimab) and temozolomide i...
Eligibility Criteria
Inclusion
- Histologically confirmed glioblastoma, radiographically or pathologically diagnosed recurrence.
- Aged ≥ 18 years.
- ≥12 weeks after postoperative radiotherapy.
- Karnofsky performance status (KPS) ≥ 60.
- Expected survival \> 3 months.
- Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):
- Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; and platelet count ≥ 100 × 10\^9/L;
- Serum albumin ≥ 28 g/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- Serum creatinine ≤ 1.5 × ULN;
- Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ).
- Thyroid stimulating hormone ≤ ULN; If abnormal, T3 and T4 levels should be examined, and if T3 and T4 levels are normal, they can be screened.
- Subjects voluntarily join the study and sign an informed consent form, with good compliance.
Exclusion
- Treatment with a dose of prednisone \> 10mg /d or equivalent dose of corticosteroids is required.
- There exist other uncontrolled central nervous system diseases unrelated to cancer.
- A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
- Uncontrolled cardiac clinical symptoms or diseases, such as New York Heart Association (NYHA) class II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
- Serious infections, such as severe pneumonia, bacteremia, and infection comorbidities requiring hospitalization, occurred within 4 weeks.
- Active autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; It does not include patients with vitiligo or childhood asthma/allergies that have healed and require no intervention as adults.
- A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
- Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.
- Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).
- Known history of psychotropic drug abuse, alcoholism and drug use.
- Not suitable for inclusion, as judged by the investigator.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06220552
Start Date
December 27 2023
End Date
December 30 2027
Last Update
January 24 2024
Active Locations (1)
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1
Yingpeng Peng
Zhuhai, Guangdong, China, 519000