Clinical Study on Intraluminal Injection of FOLactis (NCT06512896) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study on Intraluminal Injection of FOLactis
China40 participantsStarted 2023-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hemoglobin ≥ 80 g/L (no blood transfusion within 14 days);
. Absolute neutrophil count ≥ 1.5 × 109/L, and white blood cell count ≥ 3 × 109/L;
. Platelet count ≥ 90 × 109/L;
. If there is no liver metastasis, total bilirubin\<1.5 × ULN; If there is liver metastasis or Gilbert syndrome in patients with high indirect bilirubinemia, total bilirubin\<3 × ULN;
. If there is no confirmed liver metastasis, AST and ALT\<2.5 × ULN; If there is confirmed liver metastasis, AST and ALT\<5 × ULN;
. Serum creatinine ≤ 1.5 × The upper limit of normal value (ULN) and the creatinine clearance rate calculated by the Cockroft Fault formula \* are ≥ 30 mL/min;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: three years
Trial details
NCT IDNCT06512896
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School