Meaning of absolute contraindication.
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Thank you crissie for sharing your experience.
Unfortunately, I still don’t understand at which point the study manager ‘felt’ my father is not healthy enough for this treatment, if it’s not just because of the stents and PTBDs.
Thank you.
Nicolo
I work in clinical research. Firstly they are saying that your father would not be a good candidate due to the stent and bile drain because of the reason you father needed them.
A lot of time the inclusion criteria for the studies also includes the Investigator’s opinion that the subject would be a good candidate.
It appears that they are saying though this is not an “exclusion criteria” for the study that they do not feel that you father is healthy enough for the trial and are concerned that if he starts this trial he could get sicker.
Unfortunately the doctors have to make these calls.
Hi Nicolo,
The researchers associated with the trial you are interested in may be amenable to providing more explanation if you contact them again or reach out by phone.
The purpose of a trial is to test the effectiveness of a new treatment. For this reason, close attention is paid to patient selection to be sure that the statistics that come out of the trial paint a clear picture of the treatment’s outcomes for patients and document any side effects. If a patient has other health issues, there may be a determination that it would be difficult to know if an adverse outcome or side effect was due to the treatment or to the other underlying health issues. With their experience with earlier patients, they may have a sense of a patient profile at higher risk of infection. Patient selection involves careful judgment calls by doctors and researchers in charge of a clinical trial.
The message you received suggested to me that the trial doctors and researchers are concerned that the treatment might further harm your father’s weakened liver function.
I hope you can get the answers you are looking for. If you have additional medical records that would support your case, there would seem no harm to asking again about his eligibility.
Regards, Mary
Hi Mary
Thanks for your reply.
I understand that stents and PTBDs can be a higher risk for lymphodepletion phase of ACT treatment. What I don’t understand is why the stents or PTBDs is not an absolute rejection criteria for that trial, if they don’t even need to see the patient in person only with that reason. They don’t list this as rejection criteria in trial description and the study manager said it it not an absolute contraindication. That means that some patients with stents or PTBDs can be accepted to that trial. Doesn’t it? If it’s true then the rejection of my father can’t be understood. I just said he has stents and PTBDs and the bilirubin level is kept normal and that’s all. There were no submission of clinical records or other information.
We didn’t run NGS but tried to apply a few gene-based trials. FGFR I/II, IDH I/II, PD-L1 all were negative and MSI-L. Not just for the gene matching failure, in my opinion, ACT is the most promising one that can lead to a complete cure.
Thank you.
Nicolo
Hi Nicolo,
Not getting into a clinical trial of great interest must be disappointing and frustrating.
As I understood your message, it seemed that the doctors thought your father may be at higher risk of infection due to the specifics of his stents. Infection risk would be a concern in TIL trials because the treatment involves reducing then rebuilding the patient’s immune system, as I (not a doctor) understand it. Trials choose patients carefully not only to ensure safety but also to be certain their patient group fits the characteristics that enable having statistics at the end that are valid to demonstrate effectiveness.
There are many trials for cholangiocarcinoma (and solid tumor) patients, including outside the U.S. In your search, have you found others to look into? Has your father had genomic testing to see if the new targeted treatments being tested in trials would be of potential benefit?
Regards, Mary
Hello everyone.
Apologize that my first posting is a questioning, since the ‘Introduction’ board kept asking me to log in even though I already logged in.
My father is a 74-year-old intrahepatic bile duct cancer patient, diagnosed at April 2016, got surgery but have had a relapse after 1 year.
He has underwent 1st-line chemo(cisplatin + gemcitabine) and now having unofficial 2nd-line chemo(cisplatin + xeloda) due to metastases at lung. He has two stents running side-by-side in common hepatic duct for draining bile from left and right major branches, but for unknown reason stents are not working so now has two PTBDs left and right respectively, and they keep total bilirubin level below 1.0.
One month ago I found a clinical trial(NCT03801038) that I think promising and contacted the study manager for participation possibility. As my father(and I) is an international patient we contacted them via email. My father was declined to register the trial that I don’t understand clearly. Here is an excerpt of the reply from study manager.
“Stent and percutaneous bile drain are not absolute contraindications; however, this tells us that your father’s liver is not healthy or functioning appropriately enough to handle the intensive chemotherapy treatment that is required to condition the immune system to then be able to administer TIL. The biggest risk on the trial during treatment is infection given the lymphodepletion (stunting immune system) and having abnormal connections to the biliary tree in the liver can cause life threatening infections such as cholangitis. For these, reasons, it does not sound like your father would be a candidate for this treatment.”
The study manager tells that ‘stent and PTBD are not absolute contraindications’. However, they say they don’t even need to see my father for further examination. Then isn’t it an ‘absolute contraindication’? Do I have wrong understanding of ‘contraindication’?
Could someone help me understand why my father was rejected even without having any absolute contraindications?
Thank you.
Nicolo
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