Actively Recruiting
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors
Led by Shanghai Yunying Medical Technology · Updated on 2023-12-14
9
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Shanghai Yunying Medical Technology
Lead Sponsor
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
9 participants are expected to be enrolled for this open，Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with advanced bone and soft tissue tumors.
CONDITIONS
Official Title
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 75 years with soft tissue sarcoma or bone tumors confirmed by histology or cytology
- Have failed standard treatments or choose not to receive other antitumor therapies
- No absolute or relative contraindications to treatment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Expected survival of at least 3 months
- At least one measurable tumor lesion suitable for injection based on RECIST 1.1 criteria
- Adequate organ function with laboratory test values meeting specified thresholds for blood counts, kidney, liver, and coagulation parameters
- Discontinued any cancer treatments (radiotherapy, chemotherapy, biological agents) at least 28 days before starting R130
- Agreement to use reliable contraception during the trial and for 180 days after last dose if of childbearing potential; negative pregnancy test within 7 days before enrollment for females
- Voluntary informed consent and ability to comply with study requirements
You will not qualify if you...
- History of serious adverse reactions to immunotherapy not resolved to mild or none
- Severe or uncontrolled diseases including poorly controlled hypertension, significant heart disease, severe infection, past organ or bone marrow transplant, or severe immune deficiency
- Urine protein abnormalities above specified levels
- History of type I diabetes mellitus or HIV infection
- Severe thyroid or cortisol abnormalities; active or suspected autoimmune disease requiring systemic therapy
- Active tuberculosis or strongly positive OT test
- Active bleeding or severe blood clotting problems
- Received cancer treatments (endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy, herbal) within 4 weeks before first dose
- Active hepatitis B or C, immunodeficiency virus, or other significant active infections
- Recent major surgery (grade 3 or higher) or unhealed surgical wounds within 4 weeks before enrollment
- Pregnant, lactating, or planning pregnancy within six months
- Any other conditions deemed unsuitable for trial participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
P
Pan Feng, MD
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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