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Ray
Immunotherapy in Sydney/Australia

Dear Rene & Edward,
I had my right lower lobe lobectomy and left lower lobe resection performed on November 4 and November 11 2014 respectively. There were diagnosed as Stage 1B & 1A respectively. Due to its early stage, no adjuvant therapy was required. From the molecular tissue analysis, the right lung has no EGFR mutation (EGFR negative) and negative to ALK & ROS1 , while the left lung is positive to p.Leu858Arg (L858R) or Exon21 mutation. In my PET scan on December 5 2016, they detected a lesion (cancer) on my T1 Spinous Process, even though there is no other cancer detected else where in my body. Whilst a “cystic (9 mm)” and a “tiny nodular density (2 mm)” on the right middle lobe lung were mentioned in the PET, these were present since 12 October 2015 (via CAT imaging) [during that time, cyst was 3 mm & nodule was 2 mm] - my Thoracic surgeon told me in my meeting on 9 December 2016, not to worry about it as there were there since 12 October 2015 and no lung cancer was not evident on the PET dated 28 April 2016 & 5 December 2016. I underwent a resection of T1 Spinous Process on December 21 2016. From the T1 biopsy report, it is non mutated (EGFR negative), confirming the oligometastatic from my right lung.

Blood Test for EGFR T790M (Exon21 mutation) Mutation Analysis Report for T1 Spinous Process: Jan 6, 2017, performed at Olivia Newton-John Cancer Research Institute.
INTERPRETATION: Plasma DNA is a surrogate for tumour DNA. The absence of the EGFR T790M mutation in the blood does not rule out the possibility that the tumour may harbour the EGFR T790M mutation, especially since the EGFR driver mutation was not detected. This may be due to a low tumour burden. Thus, EGFR mutation testing of tumour tissue is required to exclude the presence of the mutation. If a tissue biopsy is not possible, a blood sample from this patient could be sent to us again when the tumour burden increases. My Oncologist told me that the Circulating Tumour DNA originally proposed to be done at MSKCC may bear similar results as the above and he believes this is a good result because it showed low circulating tumour burden.

I will be undergoing IMRT 30 Gy in 10 fractions over 10 days to treat the T1 Spinous Process in the next 1-2 weeks and my Oncologist recommended Chemo as well. This first line therapy is Carboplatin/Alimta for 4 cycles over a 12 week duration (1 cycle every 3 weeks) to wipe out the remaining circulating tumour before they multiply. My Oncologist cousin in Yale Comprehensive Cancer Center agreed with my Sydney Oncologist that it is potentially curable, so aggressive treatment with radiation and chemotherapy makes sense. In fact, my Oncologist did mention to do IMRT & Chemo together - I am very weary my body just can not handle these combined toxicities.

Q1: After reading your Chapter 2 & 3, I am beginning to doubt if Chemo will actually provide me with a cure?. In other words, would it just delay the inevitable recurrence of cancer?.
Looking at a back-up plan in the event the recurrence happens after Chemo, would immunotherapy still works as effective as if I have not done Chemo (I suppose this is exactly what Rene has been through)?.

Q2: How is Rene's recent neutrophil count when compared with the time she underwent Chemo?. Is Rene's bone marrow back to normal when compared with the time prior to Chemo?. Does Rene have any further side effects as a result of the Chemo?.

Q3: With my non-mutated mets to T1, do you think immunotherapy still provide a higher chances of cure when compared with Chemo?.
My Oncologist mentioned that if Chemo doesn't work (recurrence of cancer), then immunotherapy can be used as a second line therapy.

Q4: What immunotherapy is Rene currently on?.

My Chemo decision time is coming up in a week time - I am just not sure what to do honestly as I have not found a cancer centre in Sydney/Australia that can offer immunotherapy and I am very weary of the lasting side effects Carboplatin/Alimta can have. Due to the time pressure and the thought of circulating tumour multiplying, I may be forced to bite the bullet and take the Chemo option.

FYI, I have stopped taking all my omega 3 high doses, vitamins & supplements in preparation for the IMRT.

Your feedback would be greatly valued & appreciated.

Thank you

Rene and Edward Chee
chemo vs immunotherapy

Q1: After reading your Chapter 2 & 3, I am beginning to doubt if Chemo will actually provide me with a cure?. In other words, would it just delay the inevitable recurrence of cancer?.
Looking at a back-up plan in the event the recurrence happens after Chemo, would immunotherapy still works as effective as if I have not done Chemo (I suppose this is exactly what Rene has been through)?.

A1: Whether chemo will lead to a cure depends on the effectiveness of that particular treatment regimen and the type/stage of cancer. The oncologist should know the statistics for this. Usually patients need to press oncologists for the numbers. If the oncologist does not give the statistics, it's up to the patients to find it out for themselves from published clinical study reports, as we did (Chp 3). It may be difficult to find statistics for your exact situation, but you can get a general idea.

Whether chemo decreases the effectiveness is a complex question. Sometimes chemo can aid immunotherapy if some tumor cells are killed and as a result, T cells that recognize the cancer are generated. On the other hand, if chemo damages the bone marrow, the capability of the immune system to attack cancer may be diminished.

Q2: How is Rene's recent neutrophil count when compared with the time she underwent Chemo?. Is Rene's bone marrow back to normal when compared with the time prior to Chemo?. Does Rene have any further side effects as a result of the Chemo?.

A2: Rene's current neutrophil count fluctuates slightly below the lower range of normal, which is lower than before she went through chemo, and slightly higher than the time right after chemo. Her bone marrow did not bounce back to normal after chemo - supposedly other patients who got this chemo regimen usually bounce back to normal. She had doxorubicin and ifosphamide, which are very old chemo drugs and cause more bone marrow damage than some newer chemo drugs.

Q3: With my non-mutated mets to T1, do you think immunotherapy still provide a higher chances of cure when compared with Chemo?.
My Oncologist mentioned that if Chemo doesn't work (recurrence of cancer), then immunotherapy can be used as a second line therapy.

A3: To understand the chance for a cure with your chemo regimen, you need to examine the statistics (overall survival rate, progression free survival) for metastatic NSCLC patients who go through the prescribed chemo. After initial shrinkage with this chemo, is the cancer completely gone for a long period of time (ie - cured) or will it return after some time (ie - not curative, merely slowing progression)?
Immunotherapy is complex - if all the components to mount a successful immune response against the cancer is in place, there is a good chance for a cure. However, cancer immunotherapy is still being actively researched, and there is no way to know what exact immunotherapy treatments are needed for each patient to achieve a complete immune response. From the book, you will see how we attempted to do different treatments to help generate a complete immune response.

Q4: What immunotherapy is Rene currently on?.

A4: Rene is not on any immunotherapy or other treatments now. After a year of the high omega 3 (~24g omega 3 daily) and low omega 6 diet, she is currently only on ~7g omega 3 (EPA+DHA) daily, while keeping a low omega 6 diet, with roughly a 1:1 ratio of omega 6 to omega 3.

Ray
chemo vs immunotherapy

Thank you so much for your feedback Rene & Edward.

Q1: With Rene entering 3-1/2 year of cancer completely gone, apart from ~7g omega 3 (EPA+DHA) daily, what other supplements (TCM etc.) does Rene take OR do to boost the body natural immune system?.

Q2: Is Rene on ketogenic diet these days?. If not, what diet is she on for the last 3-1/2 years?. Does she eat red meat?.

Q3: Is my understanding correct to say Rene maintain 24g omega 3 (EPA+DHA) daily from July 2013 to July 2014 and then from August 2014 to now ~7g omega 3 (EPA+DHA) daily?

Rene and Edward Chee
Chp 16, section "Silence of

Chp 16, section "Silence of the Lesions" describes my transition from the high dose omega 3 to the current supplementation. I am not on supplements to boost my immune system. I am only on a low omega 6 diet, the guidelines I follow are in Chp 15, section "One cup of peanuts".

Ray
Update

Dear Rene & Edward,

Hope you are well.

I completed my 4 rounds of chemo (Carboplatin/Alimta) on April 19, 2017. I subsequently did PET/MRI and it showed NED. I then did “Oncostat Extracts” via RGCC (Greece) and the Circulating Tumor Count (CTC) came back as 3.4 cells/mL.

So far, my NK Cell count (CD57) is 80/cubic mm (April 18), 70/cubic mm (May 22) & 40/cubic mm (June 22) - I am puzzled that my highest count of 80 is 20 days from 3rd round chemo and 1 day before my 4th round. The only explanation I can think of is I took an aggressive TCM herbs: Cordyceps Sinensis, Gynostemma Makino, Ganoderma, Oldenlandia during chemo treatment. After 4th round, I changed to a different herb regime and if it doesn't improve in my July tests, I will be reverting to the same TCM herbs during chemo.

It looks to me the chemo have not wipe out the CTC. I am told by RGCC that a person with no cancer should have CTC Zero cell/mL.
My Oncologist has recommended OPDIVO® (nivolumab) even with NED. To refresh your memory, my single metastasis to T1 Spinous Process was originated from my right lung NSCLC (-ve EGFR, -ve ALK, -ve ROS1 ie. non mutated).

Given my low NK cell count and NED, I am hesitant to take up OPDIVO® (nivolumab) because I am mindful that it may not work and this in turn will bar me from participating in the improved version of immunotherapy drugs Durvalumab & Atezolizumab which are in the process of approval to go on trial.

Additionally, I am unsure the accuracy of using CTC as a measurable means for immunotherapy.

A couple of questions:
1) How do I know OPDIVO is the right immunotherapy for me?.
2) Do I need to do OTHER therapy together with OPDIVO to maximize the chances of success?. If so, what is it?.
3) How do I measure the success of OTHER therapy (increase in NK cell (CD57) count?)?.
4) Would the measurable success in OPDIVO & OTHER therapy being CTC to become zero cell/mL?. Has Rene done a CTC test?. If so, may I know the results, please?.
5) How many months after Chemo did it take for Rene NK cell count (CD57) to go back to normal of about 100/cubic mm?.
6) Would you please let me know what would you do if you are in my position?.

Thank you very much for your help.

Rene and Edward Chee
Hi Ray,

Hi Ray,

Unfortunately, medicine can be more of an art than a science because human biology is so complex and mankind has only scratched the surface of these complexities. There simply is no way to know what's the "right" choice for you - be it the choice of immunotherapy, combinations of immunotherapy, or the question of immunotherapy versus chemo.

What we've tried to highlight in our book are certain principles which can inform or guide in the decision making process. One of those principles is to carefully study the objective data of so-called "proven" modalities, then make a decision regarding the odds of success versus other more "experimental" approaches. Sometimes, early research can be a strong indicator that the "proven" is inferior to the "experimental." For example PD-1 continues to prove superiority to traditional chemo regimens for many different indications where only few years ago, conventional oncologists would have dismissed PD-1 as "no evidence." (yet a careful study of public data on pubmed/Google scholar would have informed an objective reader that early data was already far superior.)

One thing we want to say about these so-called "measurements" of NK cell counts is we don't think this is a productive inquiry. You could have a very high NK cell count but that could be completely meaningless w.r.t the body's ability to keep cancer in check, say, if NK cells are blind to your tumors. We encourage you to research the role of T cells in cancer control. While NK cells have some antitumor activity, it is widely accepted that T-cells are likely the main population that provides primary suppression of cancer. That said, scientists still haven't fully mapped the different roles of different immune cells for controlling cancer.

We ever did any CTC test, nor do we have any experience with this Greek company (accuracy of their test etc).

If I recall, it took a good 1+ year (maybe 1.5 years) after radiation & high dose ifosfamide/doxorubicin before Rene's white counts finally rebounded to the "low" range of normal.

As for what we would do in your situation, it's all described in our book. But briefly, it would be to leverage systemic immunotherapy (like Opdivo) in combination with physical ablative methodologies such as cryoablation (that have exhibited documented synergy), and/or radiation. We personally prefer cryo above radiation as cryo is more definitive (if can be done safely), including for bone tumors.

The reason we devoted a whole chapter to omega3/6 is because we think it is potentially very powerful, even though we don't have many anecdotes except patient DH, Rene's experience, and that of a personal friend who seemed to have 2-3 years of good stability from Stage IV NSCLC when used in combination with ALK inhibitor.

All the best,
Edward & Rene

PS (On an unrelated note, there is scientific rationale for high dose omega-3 in combination with radiation. You might be interested in researching that.)

Ray
Update

Hi Rene and Ed,

The recent CT & MRI tests I have done appeared to show no recurrent of disease. The Circulating Tumor Count (CTC) test on Aug 17 showed 4 CTC/8.5 mL of blood as opposed to 1 CTC on May 22.

My oncologist has said to start Opdivo IF & WHEN tumours appear on the scan - Watchful Waiting strategy. When I asked him if the efficacy of Opdivo is affected IF using Opdivo now to treat microscopic CTC vs IF & WHEN they become solid tumours (appear on scan) - his reply was No. From your book, it tells me that solid tumor would increase tumor burden load, hence stretching the Opdivo’s efficacy?. What are your thoughts?.

Apart from the natural treatment I am currently doing, noting that my White Cell Count (WCC) in particular my T cells (Lymphocyte Subsets) are still below normal range, I am pondering on which 3 treatment options to start FIRST - may I have your thoughts, please?.
Sorry to sound repetitive - the dilemma of using 1 alone is the possibility of lowering T and NK cells - does it really matter & why is that?.

1) Start Rene's 24g/d omega 3 regime or
2) Coley vaccine from Saisei-Mirai, Japan or
3) Rigvir oncolytic virotherapy from Latvia.

Have you heard of the safety, reliability and efficacy of 2 & 3?.

I would appreciate your thoughts on the combined therapy of using Opdivo with ANY of the 3 above options?.

I am mindful that the only meaningful measurable outcome is CTC (assuming that scans are clear), which is still somewhat 'experimental'.

Thank you for your generous time & effort.

Best Wishes,
Ray

Rene and Edward Chee
NED dilemmas

Your doctor may not be willing to prescribe Opdivo in your case because he may feel that Opdivo's benefit vs. risk of side effects for a NED patient is not worth it. If you are being scanned at reasonable intervals, hopefully new tumor will be detected when small and treatable.

Planning - During this time when things are calm, it's best to plan what your next steps when tumors appear. Establish relationship with doctors/clinics to make sure logistics will be minimal when you need the treatment. (Chapter 16)

Possible things to do when NED - Patient DH only did omega 3/6 and had complete remission of his sarcoma lung tumors. Personally I would start on omega 3/6 when NED, and look for immunotherapy clinical trials (such as vaccination to generate T cells against the tumor) for NED patients.

Low white counts - I struggled for a long time with this and tried many supplements/ treatments. The one time when I had elevated white counts (and I was not sick) was when I had exercised hard the day before.

Ray
Opdivo (instead of omega 3/6) when NED

Hello Edward & Rene

Hope you are well.

Some updates:-
So far, I am of NED condition (is close to a year soon). I did MRI Brain on 11/15/2017 – is all clear (NED). I will be having MRI whole spine on 11/17/2017 and PET to follow in a week or so.
I will also be doing my 3rd Circulating Tumour Count (CTC) test in Sydney on 11/20/2017.

Recapping my CTC reading:-
a) RGCC - Greece on 5/22/2017 – 3.4 CTC per mL of blood
b) Sydney on 5/22/2017 – 1 CTC per 8.5 mL of blood
c) Sydney on 8/17/2017 – 4 CTC per 8.5 mL of blood

I am about to finish my alternative therapies end of November and are planning to start the high dose omega 3 regime. However, my oncologist wishes to put me on Nivolumab (Opdivo) for a fixed duration (a few months) because he believes that is a better approach to prevent recurrence (while in NED) rather than to treat it with Nivo if and when it recurs. The measurable outcome is lowering my CTC level while on Nivo plus NED scans as well. Ideally, if CTC falls to zero consistently for a few months (plus NED) while on Nivo – that would be a clear indication that Nivo is working.

I would appreciate your opinion/thoughts of being on Nivo for a few months and then stop completely – after that, start the high dose omega 3 regime.

Is my understanding correct that we can’t do Nivo and high dose omega 3 together?.

I remembered while I was on Chemo earlier this year, I just got to eat what my body feels like eating and adhering to Ketogenic diet is not doable, especially with the side effects. So, I am unsure how doable it is to adhere to Keto diet while on Nivo – what are your thoughts, please?.

Would adhering to Keto diet (in Ketosis) say 6 months per year has more anti-cancer effect than doing Keto just 3 months per year?.

As always, thank you so much for your time and effort.

Rene and Edward Chee
Thoughts on Nivo while NED

That is really encouraging that you are 1 yr NED! It will be interesting to see if the CTC accurately reflects the absence/presence of tumor in the body.

Nivo while NED:
That is encouraging your doctor is willing to give Nivo for a few months while you’re NED. However, do keep in mind that the effectiveness of “taking the brakes off” with Nivo is dependent on having T cells against the tumor.

Because immunotherapy often requires a multi-pronged approach, personally, we prefer doing Nivo after treatments that generate T cells against the tumor (cryo, adoptive T cells etc) - see Chp 16, table 3. However, if your doctor has evidence for Nivo’s effectiveness in keeping patient NED when tumors should have recurred, that would give weight to doing Nivo while NED. Some types of cancers are known to respond well to monotherapy of PD1 - most likely because T cells against the tumor are already present.

Keep in mind Nivo is not a completely side-effect free treatment (autoimmune side effects). Weigh the pros and cons with your doctor.

The high omega 3/ low omega 6 done by itself is quite low risk, but please keep in mind the warnings/side effects about high omega 3: http://www.curingcancerbook.com/diet/high-omega-3-supplementation

Nivo with omega 3 or keto:
We don't have data to speak to the good questions regarding combining nivo with omega 3 or with keto. We can only comment on what we think we would do if we were doing Nivo -- we would not combine Nivo with high omega 3 or with keto. But we would keep to a low omega 6 diet during Nivo (http://www.curingcancerbook.com/diet/low-omega-6-diet). The science behind Nivo is still being studied, so it is hard to know what the effect of combining these supplements/diets that have strong effects on the body.

Our understanding of the keto diet and it’s effect on the immune system is that a 3-week course of the ketogenic diet is sufficient to get rid of the MDSCs. It took effort to devise ketogenic meals that work for me, but it is doable, since I only did it for 3 weeks at a time. We chose strategic times to do the keto diet when we wanted to get rid of the MDSCs. (Chp 15, sections “Combining fish oil with a high-fat, low-carbohydrate diet”, “Cancer’s fierce enablers”, How very low carbohydrate diets can deplete MDSCs”, pgs 254-257).

Ray
Update

I received my MRI whole spine results 11/17/2017- they detected a new lesion on the T2 vertebral body. Note that I had the T1 spinous process resected Dec 2016 - mets from lower right lobe NSCLC. The MRI whole spine on 9/11/2017 was all cleared - I am really puzzled because within 2 months, it developed to a new spot.

The other aspect that baffles me was, I started Keto diet from 9/9/2017 up until 11/17/2017 where the majority of my diet are macadamia nuts (120-140g/day), coconut milk (500-800 mL/day), coconut oil (2-3 Tbsp/day), 2-3 avocados per day, cashews (20g/day), flaxseed meal (70-140g/day), organic chicken (120g once or twice per week), cruciferous vegetables (150g/day), blueberry (125 g/day). I also take protein powder (http://www.amazonia.com.au/amazonia-raw-paleo-fermented-salted-caramel-c... ) about 50-75g/day. Additionally, I water fasted about 2-3 days per week plus intermittent fasting on all other days (eat between 9 am to 3 pm). For the last 69 days (9/9 to 11/17), my body is in ketosis for about 75% of the time. The only thing I have changed prior to 9/11/2017 scan was I was not in ketosis at all (no Keto diet). To me doing keto (having ketosis) accelerated the tumour growth in 69 days - does this make sense?.
My omega 6 level is quite low with the above-mentioned food I took quite consistently everyday. The only thing I haven't check is the protein powder whether it has high omega 6 because I rely on it, as part of my predominantly plant based protein diet.

I will be seeing the same neurosurgeon next week to see if is operable (to obtain bone sample for testing). Should I start high dose omega 3 fish oil now using DH's or Rene's dosage?. If not, when should I start then?. What is the time gap to stop high dose omega 3 fish oil before surgery?.

In the event if is inoperable, would radiotherapy or cryoblation induced the same abscopal effect?.
Would the sequence of treatment be radiotherapy or cryoblation first, then Nivo to follow?.

The only cryoblation practice I know of in Australia and New Zealand is Dr Brendan Buckley Interventional Radiology Associates New Zealand & possibly Dr Glenn Schlaohoff at Liverpool Hospital (Australia). I remembered reading somewhere in this forum, you came across another cryoblation practice in this region - kindly let me know please?.

I came across this trial in the state of Victoria - Pembrolizumab (Keytruda) + CVA21 in Advanced NSCLC.
http://www.australiancancertrials.gov.au/search-clinical-trials/search-r...

What are your thoughts about Pembrolizumab (Keytruda) + CVA21 Vs Nivo (alone)?

Thank you for your help.

Rene and Edward Chee
We’re sorry to hear a new

We’re sorry to hear a new lesion was detected.

My only experience with the keto diet is a short 3 week course, so I cannot speak to the effect of the keto diet for several months. References for why we decided on a 3 week keto diet to deplete MDSCs: Chp 15, sections “Combining fish oil with a high-fat, low-carbohydrate diet”, “Cancer’s fierce enablers”, How very low carbohydrate diets can deplete MDSCs”, pgs 254-257.

Another thought is the new lesion may have been growing all this time, but only was detected on the last scan due to resolution limits. There's a possibility the keto diet that you were on may not have accelerated the tumor growth, but rather it was not able to stop tumor growth.

Omega 3 guidelines I follow (when to stop, etc):
http://www.curingcancerbook.com/diet/high-omega-3-supplementation

Abscopal effect and order of treatments:
Reply #6 above: “As for what we would do in your situation, it's all described in our book. But briefly, it would be to leverage systemic immunotherapy (like Opdivo) in combination with physical ablative methodologies such as cryoablation (that have exhibited documented synergy), and/or radiation. We personally prefer cryo above radiation as cryo is more definitive (if can be done safely), including for bone tumors.”

Info on cryo doctors in Australia:
http://www.cureasps.org/forum/viewtopic.php?f=7&t=1452&p=11290

If no cryo doctor are found in Australia, these are the 2 cryo doctors in the US that we have full confidence in:
Dr. Littrup (http://www.cureasps.org/forum/viewtopic.php?f=55&t=1296)
Dr. Aoun (http://www.cureasps.org/forum/viewtopic.php?f=55&t=835)

CVA21:
I am not familiar with CVA21. In general you want to generate T cells against your tumor before PD1. You’ll need to see what data there is for CVA21 to target NSCLC tumor cells and generate subsequent T cells against the tumor cells.

Thought on Nivo alone:
(from Reply #10 in this thread)
“Because immunotherapy often requires a multi-pronged approach, personally, we prefer doing Nivo after treatments that generate T cells against the tumor (cryo, adoptive T cells etc) - see Chp 16, table 3... Some types of cancers are known to respond well to monotherapy of PD1 - most likely because T cells against the tumor are already present.”

Chapter 16 outlines our thoughts if I have a recurrence. The concepts in that chapter helped us handle when I had tumors appear. Wishing you strength in making upcoming decisions.

Ray
Treatment Plan

Hello Edward & Rene,

I commenced my Nivolumab treatment on 8th Dec @ fortnightly for 6-12 months (I think). I completed the 24 Gy, 3 fractions of radiotherapy (SBRT/VMAT) on 15th, 18th, 20th Dec. I had my original lung tumors tested and both lung tissues have tested positive for Lewis Y. This indicates that a clinical trial scheduled in 2018 may be an option. This particular trial involves the generation of a immune therapy called a ‘CAR T cell’ vaccine to fight my lung cancer. The eligibility criteria is to have more than 1 measurable mets - I don't think is desirable for me to wait for measurable mets to occur. The first line of treatment (chemo) only held back the recurrence for 6 months or so. Should I introduce a T cell therapy (yet to be determined where) during my Nivo treatment or otherwise (Stop Nivo - Start T cell therapy - Stop T cell therapy - Start Nivo again - Stop Nivo)?. Do you know of any T cell therapy centers in the Asia region (Hong Kong, China, Japan) or elsewhere?.

As always, your feedback would be really appreciated. Thank you for your help.

Rene and Edward Chee
thoughts

Personally, if I had lung tumors, I would do localized treatment with cryoablation, followed by PD1 and wait, as it takes time for immunotherapy to work. We explain our thinking about this strategy and also thoughts about adoptive T cell therapy (such as CAR-T) in Chapter 16, "What I would do if my cancer returns", pg 281-282.

The science, pros and cons of CAR-T therapy is described in Chapter 6. As far as we know, CAR-T is available as clinical trials only at this point, so you'll need to look up clinical trials in various countries to see if there are any suitable for you.

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