RANDOMIZED DOUBLE-BLIND PHASE III TRIAL OF VITAMIN D3 SUPPLEMENTATION IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER (SOLARIS) Save

Date Added
February 4th, 2020
PRO Number
Pro00096338
Researcher
Ernest Camp

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Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with previously untreated metastatic colorectal cancer. The purpose of the study is to see if adding a new drug to the usual combination of drugs can lower the chance of the colorectal cancer growing or spreading.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA) Save

Date Added
January 13th, 2020
PRO Number
Pro00096360
Researcher
Ernest Camp

List of Studies


Profiles_link
Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with colon cancer. The purpose is to determine whether to recommend chemotherapy of no further treatment after surgery for an early stage colon cancer, by taking a blood sample and testing for the presences of circulation tumor DNA (ctDNA)?

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults with Colorectal Cancer: The M&M Study Save

Date Added
October 15th, 2019
PRO Number
Pro00093504
Researcher
Daniel Reuben

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Keywords
Cancer/Gastrointestinal
Summary

This study is for older adults with colorectal cancer. The purpose is to determine if low muscle mass plays a role in side effects from chemotherapy.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Save

Date Added
October 7th, 2019
PRO Number
Pro00090649
Researcher
Paul O'brien

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, of tislelizumab plus chemotherapy to placebo (an inactive substance) plus chemotherapy on you and your Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (GC/GEJ) to find out the most effective treatment. The study will take place over 3 years 4 months and will include about 17-18 office -visits to the study doctor.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-trials@musc.edu

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy Save

Date Added
September 23rd, 2019
PRO Number
Pro00091128
Researcher
Paul O'brien

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to find out if cabozantinib in combination with atezolizumab is effective in treating liver cancer compared to sorafenib alone in people who have not received prior treatment. Subjects are being asked to take part in this clinical research study because they have hepatocellular carcinoma (liver cancer) that has not been previously treated for advanced disease.It is estimated that subjects will take study drug(s) for this study for approximately 1 to 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincial-trials@musc.edu

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment in Patients with Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Save

Date Added
August 28th, 2019
PRO Number
Pro00086110
Researcher
Daniel Reuben

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, good or bad, of tislelizumab (also known as BGB-A317) plus chemotherapy against placebo (an inactive substance) plus chemotherapy for adults with locally advanced recurrent or metastatic esophageal squamous cell carcinoma to find out which is better. Subjects may continue study treatment during their participation in the study as long as there is no worsening of disease and they don't have intolerable side effects from the study treatment

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-trials@musc.edu

A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors Save

Date Added
August 13th, 2019
PRO Number
Pro00090771
Researcher
Daniel Reuben

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to explore any changes in tumors after adult subjects (ages 18+) who have advanced pancreatic or colorectal cancer receive an immunotherapy drug, called BMS-813160, alone or together with another immunotherapy drug, called nivolumab or chemotherapy. BMS-813160 and nivolumab belongs to a class of drugs called immunotherapies. ?Immuno' in ?immunotherapy' refers to the immune system. The immune system is the body's natural defense against illnesses like colds, infections, and cancer. There is no defined length of time for this study. The exact time commitment will depend on several factors, such as availability to come for appointments, cancer's response to the study drugs, reaction to the study drugs, and the sponsor's decision of whether to continue the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 Save

Date Added
November 30th, 2018
PRO Number
Pro00079574
Researcher
Daniel Reuben

List of Studies

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin, and leucovorin called mFOLFOX6), for the treatment of gastric and/or gastroesophageal cancer and other solid tumors. The entire study (Phase 1 and Phase 3) is expected to take about 66 months to complete. MUSC is participating in the phase 3 portion only.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-trials@musc.edu

A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Cancer Save

Date Added
November 6th, 2018
PRO Number
Pro00081570
Researcher
Ricardo Yamada

List of Studies

Silhouette
Keywords
Cancer/Gastrointestinal, Liver
Summary

TheraSphere® is a humanitarian use device (HUD) for treating cancer that originates in the liver. TheraSphere® consists of millions of tiny glass beads containing radioactive yttrium-90. The glass radioactive beads (20-30 micrometers in diameter ? about a third of the width of a human hair) are delivered directly to the liver tumors. It can be used to downstage tumors to become eligible for surgery or transplantation. It is also the only medical device approved in the United States to treat primary liver cancer patients with portal vein thrombosis (PVT). TheraSphere® has been approved as an HUD based upon its safety and probable benefit.

Institution
MUSC
Recruitment Contact
Susan Norton
843 814 8874
nortons@musc.edu

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