Actively Recruiting
Clinical Study on Intraluminal Injection of FOLactis
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-07-22
40
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. The safety, tolerability and preliminary efficacy of intraluminal injection of FOLactis combined with systemic anti-tumor therapy will be evaluated.
CONDITIONS
Official Title
Clinical Study on Intraluminal Injection of FOLactis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old, male or female
- Eastern Cooperative Oncology Group Performance Status score between 0 and 2
- Confirmed recurrent or metastatic solid tumors by pathology
- Malignant pleural or abdominal effusion confirmed by pathology
- Expected survival time of at least 12 weeks
- Normal main organ and bone marrow function meeting specified blood count and liver/kidney function criteria
- At least 4 weeks since last anti-tumor therapy with toxicity resolved to grade 1 or less
- Negative pregnancy test for women of childbearing age within 14 days before enrollment
- Agreement to use contraception during the study and for 3 months after last medication
- Voluntary informed consent and willingness to follow treatment and visit plans
- Agreement to provide blood, pleural or ascitic fluid, and tissue samples
You will not qualify if you...
- Major surgery within 4 weeks before enrollment (except minor outpatient procedures)
- Uncontrolled hypertension despite medication
- Uncontrolled heart diseases including heart failure NYHA II or above, unstable angina, recent myocardial infarction, or significant arrhythmias
- History of active autoimmune diseases
- Use of immunosuppressive agents or systemic steroids at immunosuppressive doses within 2 weeks before enrollment
- Severe allergic reactions to monoclonal antibodies
- Abnormal coagulation with bleeding risks or on certain anticoagulant treatments
- Positive for HIV, HCV, or uncontrolled active hepatitis B
- Severe infection or fever within 2 weeks before treatment
- Arterial or venous thrombotic events within 6 months prior to enrollment
- Known allergy to the investigational drug
- Pregnant or breastfeeding or unwilling to use contraception
- History of neurological or mental disorders including epilepsy and dementia
- Other conditions deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, China
Nanjing, China
Actively Recruiting
Research Team
B
Baorui Liu, MD,PhD
CONTACT
L
Lifeng Wang, MD,PhD
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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