Actively Recruiting
A Clinical Safety and Efficacy 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
52 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
Researchers are studying the safety and effectiveness of a modified herpes simplex virus called R130 for treating advanced bone and soft tissue tumors, including osteosarcoma and sarcoma. This early-phase, open-label clinical trial aims to learn how this oncolytic virus works in patients who have relapsed or refractory tumors and have not responded to standard treatments or choose not to receive other therapies. Participants will receive injections of 1 to 2 ml of R130, containing 1x10^8 plaque-forming units per milliliter, directly into their tumors every 7 to 14 days. The treatment focuses on patients with measurable lesions suitable for direct injection. This single-arm study does not include a comparison group and is sponsored by Shanghai Yunying Medical Technology. During the study, patients will be closely monitored for adverse events and laboratory changes up to 6 months after treatment. Researchers will assess immune responses, disease control, duration of response, and quality of life over a 12-month period with scheduled evaluations every 6 to 10 weeks. Participants must meet certain health and organ function requirements and will be followed for safety and outcomes throughout the trial.
CONDITIONS
Brief 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 16 to 75 years
- Diagnosed with soft tissue sarcoma or bone tumors confirmed by histology or cytology
- Failed standard treatment or unwilling 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 lesion suitable for direct tumor injection
- Adequate organ function with laboratory values meeting specified thresholds for blood counts, kidney and liver function, and coagulation
- Discontinued other malignancy treatments at least 28 days before starting R130
- Agreement to use reliable contraception during the trial and for 180 days after last dose for patients of childbearing potential
- Voluntary informed consent and good compliance
You will not qualify if you...
- History of serious adverse reactions to immunotherapy not resolved to mild levels
- Severe or uncontrolled diseases such as poorly controlled hypertension, heart disease, severe infection, immune deficiency, or organ transplant history
- Urine protein abnormalities above specified thresholds
- Past type I diabetes or HIV infection
- Severe thyroid or cortisol abnormalities and active autoimmune disease requiring systemic treatment
- Active tuberculosis or strong positive OT test
- Active bleeding or severe coagulation problems
- Received antitumor therapy within 4 weeks before first dose
- Active hepatitis B or C, immunodeficiency virus, or other significant active infections
- Recent major surgery with unhealed wounds
- Pregnant, breastfeeding, or planning pregnancy within six months
- Any condition judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive intratumoral injections of the recombinant oncolytic herpes simplex virus type Ⅰ (R130) every 7 to 14 days.
Visits every 7 to 14 days for injections
Duration - Up to 12 months
Participants undergo disease assessments every 10 weeks and quality of life assessments every 6 weeks to monitor treatment response and overall well-being for up to 12 months.
Disease assessments every 10 weeks and quality of life assessments every 6 weeks
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
P
Pan Feng, MD
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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