The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma

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The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06220552
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fifth Affiliated Hospital, Sun Yat-Sen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma

Arms & Interventions

Arms

Experimental: Low-dose Radiotherapy Combined With Sintilimab and Temozolomide

Interventions

Drug: - Sintilimab

Sintilimab 200mg D1, Q3W

Radiation: - Low-dose Radiotherapy

Radiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W

Contact a Trial Team

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