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Trial Title:
The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma
NCT ID:
NCT06220552
Condition:
Recurrent Glioblastoma
Conditions: Official terms:
Glioblastoma
Recurrence
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Sintilimab 200mg D1, Q3W
Arm group label:
Low-dose Radiotherapy Combined With Sintilimab and Temozolomide
Intervention type:
Radiation
Intervention name:
Low-dose Radiotherapy
Description:
Radiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W
Arm group label:
Low-dose Radiotherapy Combined With Sintilimab and Temozolomide
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 in recurrent glioblastoma. The eligible patients are
scheduled to administered sintilimab 200mg D1 Q3W temozolomide 50mg/m2 QD and
radiotherapy 1Gy/1F D1/D2/D8/D15 Q3W for 4-6 cycles, then sintilimab for maintenance. The
overall primary study hypothesis is that the combination regimen of low-dose
radiotherapy, sintilimab and temozolomide is safe and feasible in the treatment of
recurrent glioblastoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed glioblastoma, radiographically or pathologically diagnosed
recurrence.
2. Aged ≥ 18 years.
3. ≥12 weeks after postoperative radiotherapy.
4. Karnofsky performance status (KPS) ≥ 60.
5. Expected survival > 3 months.
6. 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):
1. Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; and platelet
count ≥ 100 × 10^9/L;
2. Serum albumin ≥ 28 g/L;
3. Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine transaminase (ALT)
and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
4. Serum creatinine ≤ 1.5 × ULN;
5. 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 ).
6. 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.
7. Subjects voluntarily join the study and sign an informed consent form, with good
compliance.
Exclusion Criteria:
1. Treatment with a dose of prednisone > 10mg /d or equivalent dose of corticosteroids
is required.
2. There exist other uncontrolled central nervous system diseases unrelated to cancer.
3. 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.
4. 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.
5. Serious infections, such as severe pneumonia, bacteremia, and infection
comorbidities requiring hospitalization, occurred within 4 weeks.
6. 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.
7. A history of immunodeficiency, including HIV-positive status or other acquired
congenital immunodeficiency diseases, or a history of organ transplantation and bone
marrow transplantation.
8. 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.
9. 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).
10. Known history of psychotropic drug abuse, alcoholism and drug use.
11. Not suitable for inclusion, as judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yingpeng Peng
Address:
City:
Zhuhai
Zip:
519000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yingpeng Peng, Dr.
Phone:
07562526191
Email:
pengyp3@outlook.com
Start date:
December 27, 2023
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
Fifth Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06220552
