Actively Recruiting
Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma
Led by Huashan Hospital · Updated on 2026-04-20
10
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
S
Shanghai Yuansong Biotechnology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
The clinical study of YSCH-01 will adopt an open-label, randomized design, with a planned enrollment of 10 participants with recurrent glioblastoma. Participants will be randomly allocated to the YSCH-01 monotherapy cohort or the YSCH-01 + Atezolizumab combination cohort, with 5 participants in each cohort. The study consists of the following three phases: screening phase, treatment phase, and follow-up phase. The primary endpoint is the 1-year survival rate of participants
CONDITIONS
Official Title
Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years, male or female
- Expected survival of 12 weeks or more
- Karnofsky Performance Status (KPS) score of 70 or higher at baseline
- Histopathologically confirmed glioblastoma with first recurrence after prior surgery, chemotherapy, and/or radiotherapy
- One contrast-enhancing tumor lesion 1 to 4 cm in diameter confirmed by MRI during screening
- Eligible for tumor biopsy and Ommaya reservoir implantation based on blood, liver, kidney, and coagulation tests
- Recovered from toxic effects of prior chemo/radiotherapy (CTCAE grade 1 or less except alopecia or pigmentation) with no safety risk as judged by the investigator
- Agreement to use effective contraception during the trial and for at least 6 months after last dose if of reproductive potential
You will not qualify if you...
- History or current evidence of another primary cancer
- Known allergy to study drug or its ingredients, or history of severe unexplained allergic reactions
- Contraindication to gadolinium-enhanced MRI such as pacemaker, infusion pump, or allergy to MRI contrast
- Tumor involving brainstem, cerebellum, spinal cord, or presence of leptomeningeal disease
- Tumor enhancement extending to ventricular wall or tumor cavity fused with ventricle after surgery shown by MRI
- Ommaya puncture path crosses ventricles on preoperative MRI
- Active infection requiring intravenous antibiotics or unexplained fever above 37.5°C
- Uncontrolled systemic diseases or relevant medical history including diabetes, heart failure (NYHA Class II or higher), hypertension (Grade 2 or higher), first-degree atrioventricular block, history of myocardial infarction, myocarditis, pulmonary insufficiency, thyroid dysfunction, or recent cerebral infarction within 6 months
- Active autoimmune disease or history of autoimmune disorders such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, lupus, autoimmune vasculitis, or Wegener's granulomatosis
- Planned or required live vaccine during screening or treatment
- Any conditions that make intravenous administration of atezolizumab unsafe or unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
S
Shan Jiang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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