Recurrent glioblastoma
Conditions
Interventions
YSCH-01 single drug cohort:YSCH-01
YSCH-01 combined with Atezolizumab cohort:YSCH-01 combined with Atezolizumab
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. KPS score >=70 before treatment; 2. Expected survival >=12 weeks; 3. The study participants were patients who had previously been diagnosed with primary brain tumors by histopathology and had undergone surgical resection, chemotherapy, and/or radiotherapy and had experienced the first recurrence of brain tumors. 4. During the screening MRI, an enhanced tumor lesion measuring 1-4 cm in diameter was identified. 5. The subjects had standard hematological, liver, kidney, and coagulation function and underwent a repeat tumor surgical biopsy and Ommaya implantation. 6. The subject has recovered from the toxic effects of the previous last chemotherapy or radiotherapy (CTCAE 18 years old, male or female not limited
Exclusion criteria
Exclusion criteria: 1.Previous or current malignancy of other types; 2.It is known that you are allergic to the study drug or any of its excipients, or you have had a serious allergic reaction of unknown cause in the past. 3.Any contraindications for gadolinium-enhanced MRI, such as: personal use of pacemakers, infusion pumps, or allergy to MRI contrast agents. 4.Patients with tumor lesions in the brainstem, cerebellum, or spinal cord, as well as those with diseases of the meninges. 5.The MRI of the head shows that the tumor has a marked enhancement and has invaded the walls of the ventricles, or that the cavity of the tumor is communicating with the ventricles after surgery. 6.After preoperative head MRI evaluation, the Ommaya reservoir placement pathway was found to involve the ventricles. 7.Patients with co-infections require intravenous drug therapy, or those with unexplained fever (body temperature >=37.5?); 8.Participants with unstable control of systemic diseases or related history, such as diabetes, current or past history of organic cardiovascular disease, heart failure (stage 2 or above), hypertension (stage 2 or above), first-degree or higher degree atrioventricular block, history of myocardial infarction, history of myocarditis, pulmonary insufficiency, thyroid dysfunction, or history of cerebral infarction within the past 6 months are not eligible. 9.Participants in the study had active autoimmune diseases or a history of related diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vascular disease, or Wegener's granulomatosis. 10.Study participants are screened during the eligibility period and during the treatment period, and they are advised or required to receive any live vaccines. 11.Other situations where atezolizumab injection is not suitable for intravenous administration, as assessed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate; | — |
Countries
China
Contacts
Public ContactZhifeng Shi
Huashan Hospital, Fudan University
Outcome results
None listed