Last updated: November 28, 2021
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Gliomas
Astrocytoma
Treatment
N/AClinical Study ID
NCT04888611
KY2021-547
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age from 18 to 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Estimated life expectancy > 3 months.
- Previous first-line therapy with radiotherapy and chemotherapy, first or secondrelapse with unequivocal evidence of tumor progression.
- Pathological diagnosis or molecular diagnosis for lesion this time was confirmed to berecurrent brain glioma (WHO grade 4).
- Patients with subtotal resection or above of the tumor confirmed with contrast MRwithin 72 hours after surgery.
- No high-dose systemic corticosteroids (defined as >10 mg day-1 of prednisone orbio-equivalent for at least seven consecutive days before administration).
- No antibiotics for at least three consecutive days before administration.
- Adequate organ function defined by: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.0×10^9/L, platelets ≥100×10^9/L; hemoglobin ≥ 8 g/dL. Hepatic: bilirubin 2×upperlimit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) orcreatinine clearance >60 ml/min/1.73 m2. Electrocardiogram: normal.
- Written informed consent.
- Patient should have good follow-up compliance.
Exclusion
Exclusion Criteria:
- Pregnant or breast-feeding patients.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoingor active infection, symptomatic congestive heart failure, unstable angina pectoris,or psychiatric illness/social situations that would limit compliance with studyrequirements.
- Patients with history of immune system abnormalities such as hyperimmunity (e.g.,autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrowfailures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication ofcortisol.
- Patients with any conditions that could potentially alter immune function (e.g., AIDS,multiple sclerosis, diabetes, renal failure).
- Any previous investigational medication within 30 days before first administration ofCamrelizumab.
- History of allergy to study drug components or of severe hypersensitivity reactions toany monoclonal antibodies.
Study Design
Total Participants: 40
Study Start date:
October 26, 2021
Estimated Completion Date:
May 01, 2024
Study Description
Connect with a study center
Huashan Hospital, Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting
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