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  • gavin
    Moderator

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    https://clinicaltrials.gov/ct2/show/NCT03482102

    Gavin

    gavin
    Moderator

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    https://clinicaltrials.gov/ct2/show/NCT03482102

    Gavin

    gavin
    Moderator

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    https://clinicaltrials.gov/ct2/show/NCT03482102

    Gavin

    gavin
    Moderator

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    https://clinicaltrials.gov/ct2/show/NCT03482102

    Gavin

    gavin
    Moderator

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    https://cholangiocarcinoma.org/a-phase-ii-trial-of-durvalumab-medi4736-and-tremelimumab-and-radiation-therapy-in-hepatocellular-carcinoma-and-biliary-tract-cancer/

    https://clinicaltrials.gov/ct2/show/NCT03482102

    Gavin

    gavin
    Moderator

    Hi there,

    Hopefully someone will have experiences etc to share with you about this trial, although I have none. This is the trial here is it not?

    https://clinicaltrials.gov/ct2/show/NCT02821754

    Thought I would put a link to it on the boards as it may help people recognise it.

    I did a search of the boards for the drugs used in the trial as thought that may be of help to you and came up with these links –

    Tremelimumab –

    https://cholangiocarcinoma.org/db/search/Tremelimumab/

    Durvalumab –

    https://cholangiocarcinoma.org/db/search/Durvalumab/

    Hope some of that is of use and I keep my fingers crossed for your husband for the best possible outcome to the trial.

    My best to you both,

    Gavin

    Bdolph@nykos.net
    Participant

    My husband has Intrahepatic Cholangiocarcinoma and we are currently evaluating clinical trials.  If anyone has experience on this clinical trial, I would appreciate hearing about it.

    #97639

    In reply to: anti PD1 treatment

    lilitm
    Participant

    dear Priscilla, I’m so sorry for what your father is going through, and you and your sister with him. My dad also has metastases (peritoneal carcinomatosis and perihepatic nodes, and a tumor around the portal vein/bile ducts, which required him to get a plastic stent.)

    He does not have any genomic markers for immunotherapy either, but we are on an immunotherapy plus ablation trial at the NIH. It uses anti PD-L1 (durvalumab) and anti CTLA4 (tremelimumab) with one ablation procedure to one tumor (we did it to a perihepatic lesion, in the beginning of August, after 2 months/infusions of the immunotherapy.) The first scan at the end of Aug was stable. I hope that’s a good sign. Our next scan is next week – scared but hoping for good.

    The idea behind using ablation with immunotherapy is that the ablation (radiofrequency ablation in our case) releases neoantigens, and the primed immune system would hopefully then recognize the cancer and create an abscopal effect (go after metastases all over.)

    Apparently combination immunotherapy (like nivolumab and ipilimumab, or our combo) showed some efficacy for lung or liver cancer patients who did not express PD-1/PD-L1… as far as I know, they don’t have the data yet for biliary cancer.

    Sending my hopes and wishes with love, Lili

    #97598
    lilitm
    Participant

    Dear Elena, I’m so sorry for what your brother is going through, and you with him. He is so young – it’s so heartbreaking and shocking that this happens to our young and healthy loved ones.

    If there’s anything I’ve learned from our experience than can help, please don’t hesitate to ask… Billy might have a more similar experience with his wife since my dad has been stage IVB (due to mets) since diagnosis. It’s so good you are a PA and can be the knowledgeable one in the family. I was just a grad student in my 20s when my dad was diagnosed March 2017 but I have been studying ever since to learn as much as I can and be his advocate.

    The most important thing I would say is to ask your doctors to please send a sample of your tumor tissue for genomic testing ASAP (like at Foundation One, or MSKCC where they’re doing this testing for free for cholangio patients). If he has targetable mutations or immunotherapy indicators  – ask to test for PD-1/PD-L1 (a separate test), MSI, TMB, DNA MMR – then maybe he will respond to targeted treatment or an immunotherapy trial. I would also ask MSK about newer radiation options, like ablative image guided IMRT, or proton beam radiation.

    In terms of integrative complementary approaches – we went to MSK too, and their integrative center’s Dr. Deng gives the most basic of complementary suggestions (probiotics with bifido, coriolus, vitamin D…) I don’t think you can rely on the large institutions for the most comprehensive integrative options, but it’s hard to know what else might be helpful. I think exercise was our magic weapon, since my dad was an athlete upon diagnosis and continued to exercise as much as he could throughout chemo. My dad was on Gem/Cis for 11 months (longer than average) with stability/slight shrinkage (he also used CBD oil orally, THC (vaporizing the pure plant – some people also take THC oil orally), probiotics, the recommended supplements like vitamin D and coriolus, acupuncture (definitely helped him feel better and with neuropathy from cisplatin), ginger for nausea, healthy plant-based diet (tried for lots of organic vegetables, chickpeas, eggs, some fish/chicken when he wanted more protein…), talk therapy and journaling, and any de-stressing we could think of like comedy…) before a scan showed progression and he had to switch to Folfiri.

    They added curcumin to his supplements while he was on Folfiri for about 3 months but Folfiri didn’t work and then he needed a biliary stent. At the end of June 2018, he began a clinical trial at the NIH in Bethesda, Maryland – using immunotherapy (2 checkpoint inhibitors: durvalumab and tremelimumab) and ablation, in the hopes that the ablation will release neoantigens that can be recognized by the primed immune system. The first scan in Aug was stable and we are hoping for even better in the October scan.

    I also read the book Radical Remission and try to apply the 9 factors to my dad in some way. Sending my hopes and wishes and love,
    Lili

    #97531

    In reply to: Im new!!! HIIII

    lilitm
    Participant

    Dear Laura, I’m so sorry for what you’re going through. You are so young!! I am at a loss for words…

    If there’s anything I’ve learned from our experience than can help, please don’t hesitate to ask…

    The most important thing I would say is to ask your doctors to please send a sample of your tumor tissue for genomic testing ASAP (like at Foundation One, or MSKCC where they’re doing this testing for free for cholangio patients). If you have targetable mutations or immunotherapy indicators (ask to test for PD-1/PD-L1, MSI, TMB, DNA MMR…) – then maybe you will respond to targeted treatment or an immunotherapy trial.

    Can you ask if the goal of your chemo is eventual surgery? Are there any liver-directed therapies (Y-90, TACE, ablation?) you could do?

    My dad was on Gem/Cis for 11 months with stability/slight shrinkage (he also used cbd oil, THC (vaporizing the pure plant), probiotics, recommended supplements like vitamin D and coriolus, acupuncture, ginger for nausea, healthy plant-based diet, exercise, talk therapy and journaling, and any de-stressing we could think of like comedy…) before a scan showed progression and he had to switch to Folfiri.

    He was on Folfiri for about 3 months but it didn’t work and then he needed a biliary stent. At the end of June 2018, he began a clinical trial at the NIH in Bethesda, Maryland – using immunotherapy (2 checkpoint inhibitors: durvalumab and tremelimumab) and ablation, in the hopes that the ablation will release neoantigens that can be recognized by the primed immune system. The first scan in Aug was stable and we are hoping for even better in the October scan.

    Where are you being seen? Can you get 2nd opinions from the cholangio experts recommended by this foundation?

    I also read the book Radical Remission and try to apply the 9 factors to my dad in some way. Sending you all my wishes for healing, and lots of love
    Lili

    #97515

    In reply to: Introduction / Welcome

    lilitm
    Participant

    Hi Betti, I’m so sorry about what your dad is going through, and you with him. I am also on this board for my dad, who was diagnosed in March 2017, also stage 4 from the start.

    I appreciate the Greek way of not devastating the patient – the first oncologist my dad saw in the US was so negative and bleak… I would not listen to their time periods, because they truly don’t know how anyone will respond and the median time of a year means that people also outlive that amount. My dad is here 18 months post diagnosis, still fighting. If you saw him on the street, you would not guess what he is going through.

    I hear you completely on how hard it is to see him unrecognizably frail. I’m guessing this is his reaction to the chemo. Is there any chance they can lower the doses? They did this for my dad when he was on Gem/Cis, and he stayed on it for 11 months with stability/slight shrinkage before a scan showed progression and he had to switch to Folfiri.

    He was on Folfiri for about 3 months but it didn’t work and then he needed a biliary stent. At the end of June 2018, he began a clinical trial at the NIH in Bethesda, Maryland – using immunotherapy (2 checkpoint inhibitors: durvalumab and tremelimumab) and ablation, in the hopes that the ablation will release neoantigens that can be recognized by the primed immune system. The first scan in Aug was stable and we are hoping for even better in the October scan.

    The most important thing I would say is to ask them to please send him tumor tissue for genomic testing ASAP (like at Foundation One). If he has targetable mutations or immunotherapy indicators (ask to test for PD-1/PD-L1, MSI, TMB, DNA MMR…) – then maybe he will respond to targeted treatment or an immunotherapy trial.

    Unless he is having a major shrinkage response to the chemo, I would question whether it is the right choice for him since when surgery is not the goal, then the goal of chemo here is supposed to be extending his quality of life time – “more good days”, an oncologist told me. But if the side effects of the chemo are taking all the quality of life, then I would reassess the balance… perhaps look into metronomic/low-dose chemo?

    Can he also get a CT and not just an MRI? (They always do CT at the major institutions here in the US.) Did they say there is a chance for surgery after chemo? I think you need clear answers on this to better assess the goals of the chemo.

    There is absolutely hope – I also read the book Radical Remission and try to apply the 9 factors to my dad in some way. Sending you my hopes and all my compassion and love

    #97514

    In reply to: Walking The Road

    lilitm
    Participant

    Hi Tilly, I’m so sorry your husband is going through this, and you with him.

    I am wondering if you can get them to do a needle biopsy to send for genomic testing at Foundation One or one of the other labs, to find out if he has any targetable mutations or immunotherapy indicators? (Ask for PD-1/PD-L1 testing as well as the ones they should already include – MSI, TMB, DNA MMR…)

    He may have a better treatment option that chemo in that case… also regarding ablation – the trial we are on for my dad at the NIH right now uses immunotherapy (2 checkpoint inhibitors: durvalumab and tremelimumab) plus ablation (he got a perihepatic lesion radiofrequency ablated), in the hopes that the ablation will release neoantigens that the primed immune system can recognize.

    Sending you my warmest wishes and hopes

    #97370

    In reply to: 3rd line treatment?

    lilitm
    Participant

    Dear community, I hope everyone is hanging in there.

    Thank you so much Mary and Positivity for your kind and helpful replies last time. I’m sorry it took me so long to reply – I’m always so overwhelmed! I wanted to update you on what we ended up doing:

    – On 6/25/18, my dad entered an immunotherapy trial at the NIH pairing 2 checkpoint inhibitors with ablation.

    He has had 2 infusions so far of anti-PD-L1 (durvalumab) and anti-CTLA4 (tremelimumab).

    On 8/2/18, he had radiofrequency ablation to 2 small new perihepatic lesions. The hope is that the neoantigens released by the ablation will help the primed immune system recognize the cancer and create an abscopal effect (getting rid of all the cancer!)

    He recovered well from the ablation and just a week later was exercising again (he has also gained some of his energy back from not being on chemo since his last folfiri May 8th.)

    – On 8/11 (this past Saturday), he woke up with a fever and feeling super fatigued. By evening temp was 100.4 so the on-call NIH doctor told him to go to the ER. They ran labs, ekg, scan – could find no infection or reason for the fever, so they sent him home at 3am.

    – on Sunday, he still had the fever and fatigue – and then a rash developed! It was maculopapular, all over his chest and back and his face was red, and then appeared on his legs and arms by the next day. It does not itch. The NIH told him to use a corticosteroid cream.

    By today (8/15), temp is normal for the past 15 hours and the rash seems to be slooowly fading a bit.

    We did a biopsy and it came back as “Superficial perivascular lymphcytic rash (no vasculitis, no interface dermatitis, and paucity of eosinophils.)”

    I assume it’s the classic immunotherapy rash I have read about. But if it was an immune-mediated reaction, would that mean eosinophils should have been found?

    I hope it means the immunotherapy is working!

    I’m concerned about the low fever for several days and extreme fatigue. (I’m also concerned that a potentially immune-mediated reaction this early could mean more immunotherapy adverse affects later on?)

    If anyone has any experience or info to share, would be so grateful. Thank you!
    My warmest wishes to all,
    Lili

    gavin
    Moderator

    A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

    https://cholangiocarcinoma.org/a-phase-ii-trial-of-durvalumab-medi4736-and-tremelimumab-and-radiation-therapy-in-hepatocellular-carcinoma-and-biliary-tract-cancer/

    #95859
    JH
    Participant

    Hello everyone.

    Although this is my first time posting, I’ve been reading multiple entries on this site for information, solace, and hope.

    My 35 year old wife was diagnosed month ago with stage 4 intrahepatic cholangiocarcinoma. She was excited to begin her second in law school when she went to see a doctor for a cramp in her right abdomen. She initially thought it could be an appendicitis, and when her doctor ordered ultrasound and referred her to a larger hospital, the most horrific month of our lives began to unfold.

    After a series of CT, PET, MRI scans and a needle biopsy, they confirmed that it was ICC metasized to liver, inoperable and not suited for radiation treatment. Her PET shows about 2/3 of her liver is taken over by tumor cells, the largest one in the right lobe.

    Our oncologist suggested that she immediately begin chemo theraphy consisting of standard gemcitabine and cisplatin, and also a clinical trial for chemo-naive patients aiming to block immune checkpoint consisting of tremelimumab and durvalumab.

    She began her regiment of gem/cis two weeks ago and is thus far enduring it remarkably well. She gets fever symptoms on the third and the fourth day from the treatment, high temperature and general muscle aches. She tries to eat well and much as possible to maintain her weight. She exercises regularly and keeps up with her law school readings even though she withdrew from this semester and probably more.

    It pains to me see this otherwise beautiful, healthy, young person beginning a struggle against enormous odds. There is a fleet of family and friends that is devoted to support her through this, but I feel powerless that I can’t do anything else for her to win over this dreadful illness.

    We live in Korea and are receiving treatment here. But thus far, no doctor is suggesting a solution other than the chemo regiment that she started. Should we seek an overseas opinion from major cancer centers in the US?

    Any feedback or advise will be most appreciated.

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