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

Fifth Affiliated Hospital, Sun Yat-Sen University1 site in 1 country20 target enrollmentDecember 27, 2023

ConditionsRecurrent Glioblastoma

InterventionsSintilimab Low-dose Radiotherapy

DrugsSintilimab

Overview

Phase: Phase 2
Intervention: Sintilimab
Conditions: Recurrent Glioblastoma
Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Enrollment: 20
Locations: 1
Primary Endpoint: progression free survival (PFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 27, 2023

End Date

December 30, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Responsible Party

Principal Investigator

Yingpeng Peng

Director

Fifth Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed glioblastoma, radiographically or pathologically diagnosed recurrence.
•Aged ≥ 18 years.
•≥12 weeks after postoperative radiotherapy.
•Karnofsky performance status (KPS) ≥
•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;

Exclusion Criteria

•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.

Arms & Interventions

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide

Intervention: Sintilimab

Low-dose Radiotherapy Combined With Sintilimab and Temozolomide

Intervention: Low-dose Radiotherapy

Outcomes

Primary Outcomes

progression free survival (PFS)

Time Frame: from the first day of treatment to the follow up of 1 year

median progression free survival

Secondary Outcomes

Adverse events(from the first day of treatment to the follow up of 1 year)
overall survival (OS)(from the first day of treatment to the follow up of 1 year)