Combining low-dose radiotherapy with sintilimab and temozolomide for recurrent glioblastoma

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma: A Single-arm, Prospective Phase II Clinical Study

This study is testing a new treatment that combines low-dose radiation with two medications to see if it can help people with recurrent glioblastoma feel better and improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Drugs / interventions: prednisone, sintilimab
• Locations: 1 site (Zhuhai, Guangdong)
• Trial ID: NCT06220552 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm, phase II clinical trial investigates the efficacy and safety of a treatment regimen that combines low-dose radiotherapy with the PD-1 inhibitor sintilimab and temozolomide in patients with recurrent glioblastoma. Eligible participants will receive sintilimab, temozolomide, and radiotherapy over a series of cycles, followed by maintenance therapy with sintilimab. The study aims to determine whether this combination is safe and feasible for treating this aggressive brain cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed recurrent glioblastoma who have completed prior radiotherapy and meet specific health criteria.

Not a fit: Patients with significant comorbidities or those who have not undergone prior radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent glioblastoma, potentially improving survival and quality of life.

How similar studies have performed: While the combination of these treatments is being explored, the specific approach in this trial is novel and has not been extensively tested in previous studies.

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.

Where this trial is running

Zhuhai, Guangdong

• Yingpeng Peng — Zhuhai, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yingpeng Peng, Dr.

Conditions Recurrent Glioblastoma