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Research Outline
Prepared for Alfred | Delivered December 12, 2019
Immune System Based Colo-rectal Cancer Intervention
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Goals
To learn about new and emerging noninvasive colorectal cancer treatments, specifically stage four clinical trials that are immune system based for colo-rectal cancer,
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Early Findings
Clinical Trials.gov database indicates there are
6 studies
in the 3rd or 4th phase for immune based colo-rectal cancer treatment.
Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among
C
o
l
o
r
e
c
t
a
l
Cancer Patients
The trial may be viewed
here
.
The results will approve or disapprove the beneficial effect of using
p
r
o
b
i
o
t
i
c
s
as
a
d
j
u
v
a
n
t
therapy for CRC patient and other types of cancer to reduce the side effects of radiotherapy and raise body weight as well as improving their quality of life.
Biological-guided
M
e
t
r
o
n
o
m
i
c
Chemotherapy as Maintenance Strategy in Metastatic
C
o
l
o
r
e
c
t
a
l
Cancer
The trial may be viewed
here
.
This study is try to evaluate the effect of
c
a
p
e
c
i
t
a
b
i
n
e
m
e
t
r
o
n
o
m
i
c
chemotherapy as maintenance treatment, which compare to
c
a
p
e
c
i
t
a
b
i
n
e
conventional chemotherapy, who have responded to 16-18 months first-line chemotherapy in metastatic
c
o
l
o
r
e
c
t
a
l
cancer (
m
C
R
C
). The maintenance treatments are continued until disease progression or severe toxicity. The aim of this study is to demonstrate that
c
a
p
e
c
i
t
a
b
i
n
e
m
e
t
r
o
n
o
m
i
c
chemotherapy is non-inferior to
c
a
p
e
c
i
t
a
b
i
n
e
conventional chemotherapy. Furthermore, exploratory markers involving
a
n
g
i
o
g
e
n
e
s
i
s
(serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum tumor mutation burden(TMB), etc), are conducted via liquid biopsy.
NK Activity Modulation Induced by Intravenous
L
i
d
o
c
a
i
n
e
During
C
o
l
o
r
e
c
t
a
l
Laparoscopic Surgery
The study may be viewed
here
.
Surgical resection is the best treatment option for
c
o
l
o
r
e
c
t
a
l
cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the
i
m
m
u
n
o
s
u
p
p
r
e
s
s
i
v
e
state surrounding the
p
e
r
i
o
p
e
r
a
t
i
v
e
period was a key element of cancer cells spread.
A particular
s
u
b
t
y
p
e
of T lymphocytes, the Natural Killer cells (
N
K
s
), is the main actor of the innate immune system. Several factors of the
p
e
r
i
o
p
e
r
a
t
i
v
e
period can reduce activity of
N
K
s
such as stress, pain,
o
p
i
o
i
d
s
and general
a
n
a
e
s
t
h
e
t
i
c
s
.
L
i
d
o
c
a
i
n
e
is a local
a
n
a
e
s
t
h
e
t
i
c
that has been widely used intravenously for abdominal surgeries. Intravenous
l
i
d
o
c
a
i
n
e
has been shown to reduce pain scores, morphine consumption,
i
l
e
u
s
time and length of stay in major
c
o
l
o
r
e
c
t
a
l
surgeries. It reduced markers of systemic inflammation as well.
The authors hypothesize that the use of intravenous
l
i
d
o
c
a
i
n
e
during laparoscopic surgeries for
c
o
l
o
r
e
c
t
a
l
cancer resection will preserve
N
K
s
activity.
A
v
e
l
u
m
a
b
Plus 5-FU Based Chemotherapy as
A
d
j
u
v
a
n
t
Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer (POLEM)
The study may be viewed
here
.
The purpose of this study is to determine if
d
M
M
R
and/or POLE
e
x
o
n
u
c
l
e
a
s
e
domain mutant stage III colon cancer patients gain clinical benefit (i.e. improvement in disease free and overall survival) from PD-L1 inhibitors after standard
f
l
u
o
r
o
p
y
r
i
m
i
d
i
n
e
-
b
a
s
e
d
a
d
j
u
v
a
n
t
chemotherapy.
A
v
e
l
u
m
a
b
binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on
a
n
t
i
-
t
u
m
o
u
r
CD8+ T cells, resulting in the restoration of
c
y
t
o
t
o
x
i
c
T cell response.
The rationale of giving
A
v
e
l
u
m
a
b
after standard
a
d
j
u
v
a
n
t
chemotherapy to this well-defined,
m
o
l
e
c
u
l
a
r
l
y
-
s
e
l
e
c
t
e
d
, group is based on the fact that
d
M
M
R
and POLE
e
x
o
n
u
c
l
e
a
s
e
domain mutant
C
R
C
s
have a highly and ultra-mutated genetic profile, respectively, thus leading to a high number of
n
e
o
-
a
n
t
i
g
e
n
s
with associated over expression of immune checkpoint related proteins. This profile is expected to be highly responsive to checkpoint inhibition as suggested by data of PD-1 inhibitors in
d
M
M
R
/MSI-H metastatic
C
R
C
s
.
If this study meets the primary endpoint, using
A
v
e
l
u
m
a
b
in the
a
d
j
u
v
a
n
t
setting following standard chemotherapy would become the standard of care for patients with
d
M
M
R
and/or POLE
e
x
o
n
u
c
l
e
a
s
e
domain mutant colon cancers. Furthermore, given the availability of molecular markers for patient selection,
f
u
n
d
e
r
s
of healthcare would be more likely to fund this treatment.
Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
The study may be viewed
here
.
Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment.
t
h
e
r
a
p
y
.
Impact of Intravenous
L
i
d
o
c
a
i
n
e
During
C
o
l
o
r
e
c
t
a
l
Surgery on Pain and Immune Functions
The study may be viewed
here
.
This study evaluates the impact of
i
n
t
r
a
o
p
e
r
a
t
i
v
e
intravenous
l
i
d
o
c
a
i
n
e
administered during laparoscopic
c
o
l
o
r
e
c
t
a
l
surgery on the
i
n
t
r
a
o
p
e
r
a
t
i
v
e
r
e
m
i
f
e
n
t
a
n
i
l
consumption as well as postoperative pain and
o
p
i
o
i
d
requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous
l
i
d
o
c
a
i
n
e
.
UCSF Clinical Trials- University of San Francisco
UCSF lists 38 clinical trials. They may be viewed
here
.
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