Many Cancer Patients May Have Unrealistic Hopes When They Decide To Participate In Early Stage Clinical Trials

This is a one center study defining the expectations of patients entering Phase I clinical trials: … 30235/full

I think it's an important read for all contemplating an early stage trial


Here is a brief update on the NCI MATCH INTERIM ANALYSES

Physicians are encouraged to select only those patients able to tolerate being off treatment for up to six weeks

This is a nationwide trial that is not only available at large cancer centers, but it is available LOCALLY  at COMMUNITY HOSPITALS.  In fact, the majority of patients are enrolled in the local community hospitals. MATCH is hoping to increase participation of cancer centers currently performing currently performing tumor testing in people with advanced cancer.  Additionally, there are plans for collaboration with commercial sequencing labs  to notify physicians of relevant NCI-MATCH treatment arms for their patients who have matching mutations.

To conduct clinical trials for the treatment of cancer in a consistent manner across many participating hospitals, cancer centers, and clinics requires the use of standard criteria for measuring how the disease impacts a patient’s daily living abilities (known to physicians and researchers as a patient’s performance status). The ECOG Scale of Performance Status is one such measurement. It describes a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).

In order to be considered for enrollment, patients  have to have a good health status as defined in ECOG.
Patients must be fully active, able to carry on all pre-disease performance with out restriction  (ECOG status 0)
patients may be restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work (ECOG performance status 1)

The NCI MATCH enrollment status,  as of October 16, 2016, consists of 230 patients of which 47 are cholangiocarcinoma patients, representing 2.7% of all patients.

Recent changes to the trial include allowance of tumor tissue obtained 6 months prior to registration.  This is development is particularly beneficial to our patients, as tumor tissue can be difficult to retrieve and often times patients had to undergo an additional biopsy in order to register for this trial.

As of now, the trial mandates needle aspiration as well.  The latter will be a lesser problem, as the majority of cholangiocarcinoma patients have this procedure done for diagnostic purpose. 

Resources for NCI MATCH

Main webpages:                                     

For e-mail inquiries contact:


(56 replies, posted in Introductions!) are welcome, we are in this together and you are a fantastic advocate for your Mom.

Marion are welcome and thank you for providing the ID No. which in turn led me to the identifier
This is the trial:

How is Sean feeling?  BTW: my oldest son's name is Sean as well, spelled identically. 

I assume the three prior TACE treatments are considered part of the protocol, correct? 



(4 replies, posted in General Discussion)

Nancy....the way I understand it and in simple terms,  it's all about the function of the liver and how much volume it has to do so.  This pertains to surgery as well.  Depending on the tumor location and size, there must be enough viable liver to keep the patient alive. 
Here is a an overview of SIRT:
It's focused on metastases, but it offers good education on this treatment.


Sometime soon IBM's Watson will contain your medical information and guide the steps to treatment: … rm=5963636

Thanks, Gavin.  This is a good site, easy to understand video explaining the function of the immune system  and how molecules trick the immune system from recognizing the foreign invader.

Shellie....I so much wish for an upward swing with this roller coaster. Blood transfusions to raise hemoglobin levels are not an uncommon procedure.  Someone once likened it to a "pep" pill by feeling better instantly.  I hope this is the same for Dale.

You had mentioned biopsy.  Was it tested for molecular alterations (faults?)

I can't recall anyone (on this site) treated with IPT.  Information does not look very promising: … r/ipt.html

Stay strong, dear Shellie, we are behind you all the way.


(6 replies, posted in In Remembrance) heart is heavy for you and your family.  You did everything possible to find answers to your Mom's cancer, she raised a wonderful daughter and must have been so proud of you. 
My husband passed in 2007  due to cholangiocarcinoma and two years ago I lost my Mom to natural causes.  I can relate to your pain and wish for your heart to day at a time.

Love and hugs,


Liverstrong....fantastic news.  I have high hopes for Sean, he is young and has recovered well from previous treatments.  You have a great team of physicians working on Sean's behalf. So happy for you.

I seem to have problems identifying the study, found a few, but none specifically mention cholangiocarcinoma.

Is it possible for you to supply us with the Identifier?

Hugs and the best of luck,


(1 replies, posted in Members' Cafe)

Pat...what a great tip to share with us.  In my opinion, nothing soothes like soaking in a hot tub, but it appears to appeal more to women than to men.  Wonder why that is so?

What is adoptive T-Cell Therapy?
Adoptive T-cells transfer focuses on enhancing the body’s own T cells to fight  cancer.

There are two main types of adoptive immunotherapy:

1.  Adoptive Cell Therapy.
This involves collecting and isolating the tumor-infiltrating lymphocytes  (T cells ) from a patient’s tumor, expanding them to large numbers and then re-administer to the patient.

2.  Chimeric Antigen Receptor T-cells, also called CAR-T
Again, T- cells are collected from the patient’s tumor and re-infused in the patient.  But unlike adoptive T-Cell Therapy, where the cells are grown in large numbers, CAR-T therapy involves engineering the T cells with new receptors.  These new receptors recognize specific antigens on the surface of the cancer cells.
(What are antigens: a protein expressed by a bacteria or virus that is recognized by the immune system as foreign which can stimulate the production of antibodies and combine specifically with them)

In both cases the T cells multiply, seek and destroy the cancer cells that carry those specific antigens. 

Both types of immunotherapy treatments are investigational. Patients must qualify to participate in clinical research studies.


The Blue Ribbon Panel presented its report to the National Cancer Advisory Board on September 7, 2016.  NCI then transmitted the final revised version to the Vice President on October 17, 2016.  The final report describes 10 transformative research recommendations for achieving the Cancer Moonshot's ambitious goal of making a decade's worth of progress in cancer prevention, diagnosis, and treatment in just 5 years.

Read more here and watch attached videos here: … hite+house

Today in the Oval Office, Vice President Joe Biden delivered the Cancer Moonshot report to the President and the American public. … hite+house

Being a caregiver to someone you care about may mean helping with daily activities such as going to doctor’s visits or preparing food. It can also be coordinating care and services or offering emotional support. But during this time, it’s important that caregivers take care of themselves, too.

This booklet covers:

Understanding the changes that come in your life with caregiving
How to cope with your feelings and ask for help
Tips on caring for both your physical and emotional self
How to talk with your kids about cancer
Communicating with your loved one who has cancer
Dealing with other family members and friends

You may download as PDF, receive on kindle, or order e-book. … ng-treated

The MATCH trial is accompanied by another study examining whether educating patients with cancer about genetic testing will increase their knowledge and reduce their stress levels after receiving the results of their tumor profiling tests.

Questions addressed:
What do you hope to learn from COMET?
How do you think COMET participants will react if they're among those who don't have a match?
What about patients who receive uncertain results or results that could affect their family members?
How will COMET benefit people in NCI-MATCH who are not matched with a treatment?
How quickly could the COMET study results change how doctors interact with their patients regarding genetic test results?
COMET is an ELSI (Ethical, Legal, and Social Implications of medical research) study.  How can studies of this type broaden the impact and effectiveness of treatment trials?

The answers are found here: … =eb_govdel

Rick....a warm welcome to the club no one wants to belong to, but is happy to have found.
Brushings are inconclusive in about 65% of cases, biopsies - minus a few exceptions - nearly always are warranted.
Stents can and will clog with debris, hence you would want to make sure to check your temperature and carry with you - at all times - the biliary emergency card. 
Here is the explanation and link to download: … tion-card/

Princess Margaret has an exception team of physicians focused on this cancer.  Hoping you will receive an appointment real soon. When speaking with the oncologist, you will be able to receive information on a Keytruda clinical trial, but as far as I know, prior chemotherapy had to be administered.  Balloon therapy, are you wondering whether it is a better option than stent insertion?  We have seen it rarely as stents (most often) are inserted directly through the tumorous issue.
I am with you on hoping the diagnosis will be that of a different disease, but know that treatment for cholangiocarcinoma have increased drastically, as have the positive outcomes.
In the meantime, dear Rick, stay positive, much has yet to be confirmed, continue to enjoy your activities and know that you have a global group of patients and caregivers by your side.

I am looking forward to others joining in to share their personal thoughts with you.


Thanks for that, dear Gavin.

Just released from Medical Oncology (ESMO) Congress in Copenhagen … rm=5950458

What are the Prognostic and Therapeutic Implication?

The 46 genes in the panel for detection of targetable mutations included: AKT1, BRAF, FGFR1, GNAS, IDH1, FGFR2, KRAS, NRAS, PIK3CA, MET, RET, EGFR, JAK2, MPL, PDGFRA, PTEN, TP53, FGFR3, FLT3, KIT, ERBB2, ABL1, HNF1A, HRAS, ATM, RB1, CDH1, SMAD4, STK11, ALK, SRC, SMARCB1, VHL, MLH1, CTNNB1, KDR, FBXW7, APC, CSF1R, NPM1, SMO, ERBB4, CDKN2A, NOTCH1, JAK3, and PTPN11

There are significant genetic differences between intra and extrahepatic CCA.

IDH1 and DNA repair gene alterations occurred more frequently in intrahepatic CCA
as well as  TP53 (35%), KRAS (24%), ARID1A (20%), IDH1 (18%), MCL1 (16%) and PBRM1 (11%).

extrahepatic group had higher occurrence of  ERBB2 genomic alterations
as well as  TP53 (45%), KRAS (40%), ERBB2 (25%), SMAD4 (25%), FBXW7 (15%) and CDKN2A (15%)

read more:

Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Resectable Hilar Cholangiocarcinoma (Klatskin Tumor.) … amp;rank=1

Jojo..........happy to hear that everything worked out well.  Please know  patients with cholangiocarcinoma (bile duct cancer) are at risk for a serious complication called ascending cholangitis; a bacterial infection of the biliary system, which can be fatal.   The risk of this complication is highest in patients with biliary stents, biliary drainage tubes and/or patients who have had an ERCP or other medical procedure on the biliary tree. Patients must be acutely aware that temperature readings are of most importance, daily is best.
Additionally, we advice patients to carry on hand a biliary card.  You may download the information here:

Good luck on the MRI test results and please keep us informed.   We care and we are in this together.


Loganrox....we  call this scan-anxiety and I can't think of one single person feeling different than what you are expressing.  Hang in there, know that we are sending tons of good wishes your way and the odds are very much in you favor.  Please let us know how things develop.


The Cancer Letter addresses this issue with several specialist.   Use this link:

Scroll to:

scroll down and click on:
Conversation with The Cancer Letter
Perspectives on Clinical Development of PD-1 Drugs

click on:
1. Is there a reason to believe that these drugs are different from each other?
2. Will this number of trials produce data showing how these drugs compare to each other and how they should be used?
3. In your opinion, which of these PD-1 and PD-L1 one drugs are going to be the best? How could companies or other individuals tell whether their drug will be better than another drug? Is there a way to tell whether some of these drugs should not go past Phase I?
4. Should there be national leadership in command or in control that determines which of these drugs will not be viable? Why doesn’t anybody do that?
5. Is there a common biomarker assay? Do these companies have uniform toxicity management? How will these drugs be studied in combination? How will they be studied in the adjuvant setting?

6. How can these drugs be approved? Can FDA handle the onslaught of drugs?

7. 166,736 patients are enrolled or will be enrolled in these clinical trials as of Sept. 9. Is that too many? Is the push towards PD-1 and PD-L1 drugs getting in the way of other trials or the possible development of other types of treatment?

8. Is the large number of PD-1 drugs in development slowing down the approval of the best drugs for treating patients?

This is a great event, Ben.  I will be there as well to cheer up each and everyone joining in. 
Please, come and meet us in Berkeley, CA, November 20th, 2016.

Hope to see you there.