Actively Recruiting
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Led by Shanghai Yunying Medical Technology · Updated on 2023-07-27
20
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
S
Shanghai Yunying Medical Technology
Lead Sponsor
L
Linyi People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
20 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 solid tumors.
CONDITIONS
Official Title
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with solid tumors confirmed by histology or cytology
- Failed standard treatment or unwilling to receive other antitumor therapies
- Age between 18 and 75 years
- ECOG performance status score of 0 to 2
- Expected survival of at least 3 months
- At least one measurable lesion suitable for intratumoral or intraperitoneal injection
- Adequate organ function with laboratory values within specified limits for blood counts, kidney and liver function, and coagulation
- No absolute or relative bleeding contraindications
- Women of childbearing potential must have a negative pregnancy test and agree to use reliable contraception during and for 180 days after the trial
- Voluntary informed consent and good compliance
You will not qualify if you...
- History of serious adverse reactions to immunotherapy
- Severe or uncontrolled diseases such as uncontrolled hypertension, significant heart disease, severe infections, or immune deficiencies
- Urine protein abnormalities exceeding specified limits
- Past history of type I diabetes or HIV infection
- Severe thyroid or cortisol abnormalities or active autoimmune diseases requiring systemic therapy
- Severe prior lung changes
- Active tuberculosis with strong positive OT test
- Active bleeding or severe blood clotting problems
- Antitumor therapy within 4 weeks before first dose
- Unresolved toxicities from previous cancer treatments above grade 1
- Active hepatitis B, hepatitis C, immunodeficiency virus, or other significant infections
- Recent major surgery with unhealed wounds within 4 weeks
- Pregnancy, breastfeeding, or planning pregnancy within six months
- Any other condition making participation unsuitable as judged 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
Linyi Central Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
F
Feng Pan
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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