Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06220552

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

Led by Fifth Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-01-24

20

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed glioblastoma with radiographic or pathological diagnosis of recurrence.
  • Age 18 years or older.
  • At least 12 weeks after completing postoperative radiotherapy.
  • Karnofsky performance status of 60 or higher.
  • Expected survival longer than 3 months.
  • Adequate organ function including hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, serum albumin ≥ 28 g/L, total bilirubin ≤ 1.5 times upper limit of normal (ULN), ALT and AST ≤ 2.5 times ULN, serum creatinine ≤ 1.5 times ULN, clotting times within acceptable ranges, and normal thyroid function or normal T3 and T4 if thyroid stimulating hormone is abnormal.
  • Voluntary informed consent with good compliance.
Not Eligible

You will not qualify if you...

  • Requirement for prednisone doses greater than 10 mg per day or equivalent corticosteroids.
  • Presence of uncontrolled central nervous system diseases unrelated to cancer.
  • History of other malignant tumors within the last 5 years or at enrollment, except for cured skin basal cell carcinoma, cervical in situ cancer, or thyroid papilloma.
  • Uncontrolled cardiac symptoms or diseases such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction within 1 year, or significant arrhythmias needing intervention.
  • Serious infections like severe pneumonia or bacteremia requiring hospitalization within 4 weeks.
  • Active autoimmune diseases including interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism, excluding resolved vitiligo or childhood asthma/allergies.
  • History of immunodeficiency including HIV infection, organ or bone marrow transplantation.
  • Active tuberculosis infection currently or within 1 year prior to enrollment without formal treatment.
  • Active hepatitis B or C infections based on viral load or antibody tests.
  • Known history of psychotropic drug abuse, alcoholism, or drug use.
  • Any condition judged unsuitable for inclusion by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yingpeng Peng

Zhuhai, Guangdong, China, 519000

Actively Recruiting

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Research Team

Y

Yingpeng Peng, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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