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

NCT06220552 | Recruiting Phase 2

• 1 other identifier: ZDWY.TJBZLK.003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  median progression free survival

  from the first day of treatment to the follow up of 1 year

Secondary Outcomes (2)

• overall survival (OS)

  from the first day of treatment to the follow up of 1 year

• Adverse events

  from the first day of treatment to the follow up of 1 year

Study Arms (1)

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide

EXPERIMENTAL

Drug: Sintilimab; Radiation: Low-dose Radiotherapy

Interventions

Sintilimab DRUG

Sintilimab 200mg D1, Q3W

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide

Low-dose Radiotherapy RADIATION

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

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Yingpeng Peng

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

sintilimab; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yingpeng Peng, Dr.

CONTACT

07562526191; pengyp3@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: January 24, 2024
• Study Start: December 27, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (1)