HELP choose clinical trial

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  • #90292
    marions
    Moderator

    Iyvyo….Kudos to you for becoming involved.

    Most likely already you know: metastases are difficult to treat. That is the case not only for cholangiocarcinoma, but it is the case for all cancers.

    This is the way I understand it: a group of molecules in a cell work together to control functions such as cell divisions or cell death. This is called a signaling pathway. Mutations happen and disrupt this process and cancer develops.

    It is believed that anywhere from 0 to 22% of intrahepatic cholangiocarcinoma patients harbor the BRAF V6000E mutation for which the combination of Trametinib and Dabrafenib is being tested in clinical trials. The below study explains more:
    https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001705-87/AT

    Do you know whether the patient has been tested for other mutations? Did she have a recent biopsy?

    We must understand that clinical research studies are meant to further science and that patients may or may not benefit from enrolling in such a trial. It truly is a personal choice.

    I agree with you in that it is best to await the outcome of the upcoming appointments and to go from there.

    Please stay in touch. We care and we are in this together.

    Hugs
    Marion

    #90291
    mbachini
    Moderator

    Dear Iyvyo,

    Welcome to this group. I know you will find much support here. I have been in a clinical trial for the past 3 years, and fortunately having a great response. I don’t know much about the trials in Italy, but as with any treatment, gather as much information as possible and your girlfriend’s mom will have to choose what she feels best about. Please keep us posted on what she decides and on what her progress is. Hugs and prayers your way!
    Melinda

    #90290
    middlesister1
    Moderator

    Dear Iyvyo,

    I’m glad you found our group and it is great that you are doing so much to help your girlfriend’s mother. I’m sorry to hear that it appears the cancer has returned after resection. And, unfortunately it is not unusual for patients and caregivers to do a lot of research on their own. Most important is to have treatment at a hospital which has experience with CC.

    On the newly diagnosed webpage, there is a link to information about clinical trials.

    http://cholangiocarcinoma.org/newly-dx/

    I’m also hoping that we may have some members from Italy who could chime in with helpful hints.

    Best wishes,
    Catherine

    #11838
    lyvyo
    Spectator

    Hi all,

    I’ve found since few days this wonderful communty and I’m stil reading every post, so admin please excuse if double-posting or ot, and THANK YOU to mantain active this website. This is so much important.

    At the beginning of this year my girlfriend’s mother was diagnosticated with a Intra-hepatic cholangiocarcinoma, resected on 03/2015. At the time, everything was looking just fine, but on 08/15 various focalities appears in the liver again, and since then it was a rush of bad news with hepatic and pulmonary metastasis.

    Long story short, we are currently waiting for approval for BRF117019 clinical trial, in Milan, Italy (we’re from Italy).
    In the meantime, we was asked by our Doctor to start a research for other clinical trials.
    That was really surprising to me. I’m not a doctor or an expert…. what is supposed I should look for????
    Anyway, me, my girfriend, all the family and friends have started contacting many other honcologists here in Italy, explaining the situation again and again to everybody, seeking for any possible solution.
    In the next few days we have some appointments with 3-4 doctors, and will see which solution will be the most promising one.

    The problem I’m facing now is that, simply and clear, all the doctors here in Italy to whom we have spoken to date, are completely unaware of clinical trials which are not available in Italy or in their own hospital.
    Because of this, as an idiot I’ve started my research and found this website.
    I’ve found many Clinical trials in US and EU. We are not interested in blinded or palliative trials. not yet. We are looking for the most promising trial available worldwide.
    I’ve found so many trials that is impossible to me to choose some of them, or understand which one could work for my girlfriend’s mother situation. I’m completely lost.

    Here below I copy-paste the last report from Dr K.D. of National Cancer Institute in Milan.
    I would really appreciate if someone can advise the best trials out there for this situation.
    Any help, of course, is really important.
    Thank you for your time. All the best.
    Livio

    SPECIALIST EXAMINATION REPORT
    Mrs *********** ADA born on 27/04/1951
    Examination date: 28/10/2015

    ****Oncological illness
    Next pathological anamnesis on the current pathology:
    2000 left mastectomy due to infiltrative ductal carcinoma pTIcN0
    It follows the adjuvant therapy with wall CMF + RT and tamoxifene 20 mg/day for a few months, then interrupted for intolerances. Negative follow-up till 2008.
    2008 right QUART due to infiltrative ductal carcinoma pTIcN0; positive RRHH, Ki67=40%
    It follows the adjuvant therapy with anastrozole for 5 years. Negative follow-up till 2015
    02/2015 abdomen RMN single hepatic lesion of the first segment
    Markers CA 15.3 = 34 and CEA = 5.2
    03/2015 PET: hepatic lesion with increased carbohydrate-metabolism
    Markers CA 15.3 = 30.5; CA 19.9 = 6.3; CEA 7.56; CA 125 = 17.3
    17/03/2015 hospitalization due to resection of suspicious hepatic metastasis. She undergoes anatomical resection of the caudate lobe with plastic surgery of the hepatic back vena cava. Not very differentiated adenocarcinoma and with areas of necrosis in the hepatic area; morphological and immunophenotypic framework compatible with mass forming G3 intra-hepatic cholangiocarcinoma, with microscopic vascular invasion and infiltration of the fibrous tissue of the segmental portal vein. Resection margin undamaged.
    She reports having started an adjuvant therapy very likely with Gemcitabine 04/2015 (NO DOCUMENTATION HAS BEEN PRESENTED)
    21/08/2015: in the superior abdomen RMN: in the liver there are focalities distributed at a peripheral level, which are suspicious due to recurrent cholangiocarcinoma
    09/2015 => 10/2015 CT of I line with capecitabine
    28/09/2015 Hepatic biopsy. EI: cholangiocarcinoma metastasis
    24/10/2015 CAT T/A: illness of pulmonary and hepatic PD

    ****Oncological diagnosis
    Intra-hepatic cholangiocarcinoma operated in previous bilateral breast carcinoma treated with adjuvant hormone-therapy.
    Patient evaluation

    ****Subjectivity
    Subjectively well, except for abdominal pains

    *****Clinical synthesis
    In relation to the clinical history the patient can be taken into consideration for experimental treatment in the experimental protocol of the phase II with BRAF inhibitor +MEX inhibitor (protocol BRF117019) Suitably informed she accepts and signs the consent to the screening (v. 3 on 30/07/2015). A copy is handed.
    The patient can be included also in the protocol of phase I (ALKA-372-001). Suitably informed she accepts and signs the consent to the screening (v. 4 of 26/02/2015). A copy is handed.

    ****Next appointment
    Notes of next appointment
    11/09/2015 Appointment in room 12.

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