Pilot
Study Title: Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To study the safety and effectiveness of continuous hepatic arterial infusion of floxuridine alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery
Primary Outcome Measures: Dose-limiting toxicities [time frame: completion of two cycles of treatment by all patients (approximately 4 years)]
Principal Investigator: William Chapman, MD, Washington University School of Medicine; (314) 362-7792, chapmanw@wustl.edu
ClinicalTrials.gov Identifier: NCT01525069
Phase I
Study Title: Phase I Trial of Radiation Therapy in Patients With Liver Cancers and Impaired Liver Function
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: MD Anderson Cancer Center
Purpose: To find if new methods of giving radiation to the liver can be given safely to patients who already have liver problems
Primary Outcome Measures: Maximum Dose Constraints for Two Radiation Regimens [time frame: 2 months after completion of radiation therapy]
Principal Investigator: Eugene J. Koay, MD, PhD, MD Anderson Cancer Center; (713) 563-2300
ClinicalTrials.gov Identifier: NCT02626312
Study Title: A Pilot Study of Tremelimumab—A Monoclonal Antibody—Against CTLA-4 in Combination With Trans-Arterial Catheter Chemoembolization, Radiofrequency Ablation, Stereotactic Body Radiation Therapy or Cryoablation in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinomas
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute, National Institutes of Health Clinical Center
Purpose: To test the safety and effectiveness of tremelimumab with transarterial catheter chemoembolization or radiofrequency ablation for advanced liver cancer
Primary Outcome Measures: Safety and feasibility of combining tremelimumab with trans-arterial catheter chemoembolization or radiofrequency ablation in patients with advanced hepatocellular carcinoma [time frame: end of treatment]
Principal Investigator: Tim F. Greten, MD, National Cancer Institute; (301) 451-4723, gretentf@mail.nih.gov
ClinicalTrials.gov Identifier: NCT01853618
Phase II
Study Title: A Phase II Study Using LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization Alone or Combined With Thermal Ablation
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Institutes of Health Clinical Center
Purpose: To test an embolization material called LC LUMI beads to see if it can block blood vessels that provide blood to cancerous liver tumors and to see how the beads look on x-ray and CT images
Primary Outcome Measures: To determine the imaging characteristics of radiopaque beads in the treatment of hepatic tumors using bead embolization [time frame: 2 years]
Principal Investigator: Bradford Wood, MD, National Institutes of Health Clinical Center; contact Charisse Garcia, RN, (301) 594-4511, garciacr@mail.nih.gov
ClinicalTrials.gov Identifier: NCT02649868
Study Title: Phase II Trial of Sorafenib in Combination With Modified FOLFOX in Patients With Advanced Hepatocellular Carcinoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Massachusetts General Hospital
Purpose: To determine if sorafenib, the standard treatment, is effective when combined with modified FOLFOX, an FDA-approved treatment for colorectal cancer, which has shown some antitumor activity in liver cancer
Primary Outcome Measures: Time to progression [time frame: 2 years]
Principal Investigator: Andrew Zhu, MD, PhD, Massachusetts General Hospital; contact Daniel Harris, (617) 726-8478
ClinicalTrials.gov Identifier: NCT01775501
Phase III
Study Title: Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection
Study Type: Interventional/Randomized/parallel assignment
Study Sponsor and Collaborators: MD Anderson Cancer Center
Purpose: To learn if there is a difference in patients’ quality of recovery if they receive one of two standard kinds of pain control treatments after surgery on the liver and/or pancreas— intravenous pain management and epidural pain management
Primary Outcome Measures: Mean postoperative pain scores [time frame: 5 days postoperative]
Principal Investigator: Jean-Nicolas Vauthey, MD, MD Anderson Cancer Center; (713) 792-6940
ClinicalTrials.gov Identifier: NCT01438476
Phase IV
Study Title: A 36-Month Multicenter, Open Label, Randomized, Comparator Study to Evaluate the Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: Baylor Research Institute
Purpose: To determine if the use of everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma
Primary Outcome Measures: Disease-free survival defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first [time frame: through month 36]
Principal Investigator: Goran Klintmalm, MD, PhD, Baylor Health Care System; contact Darlene Bunpian, MPH, darlene.bunpian@bswhealth.org, or Sharon Primeaux, MS, sharon.primeaux@bswhealth.org.
ClinicalTrials.gov Identifier: NCT02081755 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
