Patients will receive DCD after therapy after the abdominal reperfusion protocol.

Liver Transplant; Complications

Ischemia Reperfusion Injury

Cirrhosis

Liver Cancer

Liver Metastases

End Stage Liver Disease

Abdominal Regional Perfusion

Abdominal Regional Perfusion in Donation After Cardiac Death for Multi-Organ Transplantation

Transient non-functioning of the liver transplant but with usual recovery to full functioning liver

Non-anastomotic biliary stricture without other identifiable etiology

Patient Mortality at any time post transplant

Need for retransplant secondary to graft failure of any cause, or death

Imaging or biochemical evidence of anastomotic stricture requiring intervention

Imaging or endoscopic evidence of bile leak requiring antibiotics or percutaneous drainage

Overall duration of stay in hospital post-transplant

Frequency of return to the operating room for any reason

Ephraim Tang

Clinical Fellow, Multi-Organ Abdominal Transplant

London Health Sciences Centre

Patients receive cisplatin IV followed by gemcitabine hydrochloride IV on days 1 and 8, and ricolinostat PO on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Non-Resectable Cholangiocarcinoma

Recurrent Cholangiocarcinoma

Stage III Extrahepatic Bile Duct Cancer

Stage III Intrahepatic Cholangiocarcinoma

Stage IIIA Hilar Cholangiocarcinoma

Stage IIIB Hilar Cholangiocarcinoma

Stage IVA Extrahepatic Bile Duct Cancer

Stage IVA Hilar Cholangiocarcinoma

Stage IVA Intrahepatic Cholangiocarcinoma

Stage IVB Extrahepatic Bile Duct Cancer

Stage IVB Hilar Cholangiocarcinoma

Stage IVB Intrahepatic Cholangiocarcinoma

Unresectable Extrahepatic Bile Duct Carcinoma

Cisplatin

Gemcitabine Hydrochloride

Laboratory Biomarker Analysis

Pharmacological Study

Ricolinostat

Mayo Clinic in Arizona

Mayo Clinic in Florida

Mayo Clinic

Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma

A Phase Ib, Open-Label, Dose- Escalation Trial of ACY-1215 in Combination With Gemcitabine and Cisplatin in Patients With Unresectable or Metastatic Cholangiocarcinoma

Responses will be summarized by simple descriptive summary statistics.

Will be evaluated using all cycles of treatment. Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by tumor group). The number of responses may indicate further evaluation for specific tumor types in a Phase II setting.

Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures like response will be carried out in an exploratory manner.

National Cancer Institute (NCI)

Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.

Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.
Gemcitabine
Cisplatin
Low dose whole liver and portal lymph node basin radiotherapy

Treatment

Sex: Female, Male

Ethnicity (NIH/OMB)

Region of Enrollment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.
Gemcitabine
Cisplatin
Low dose whole liver and portal lymph node basin radiotherapy
decision was made to close the study due to the futility of the regimen in the first 6 subjects, as well as the lack of funding to complete the study.

Number of Participants With Radiographic Disease Response After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

Number of participants with adverse events during combined low-dose radiotherapy and gemcitabine-cisplatin treatment.

Number of Participants With Adverse Events.

Measured post-operative complications include (but not limited to) bile leak, liver failure, ascites, infection, any organ failure or insufficiency, venous thromboembolism, and mortality.

Number of Participants With Post-operative Complications After Partial Hepatectomy After Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

Tumor tissue will be obtained by either biopsy or liver resection after combination chemoradiotherapy. Histologic response will be determined by extent of viable tumor, tumor necrosis, and surrounding fibrosis.

Number of Participants With Histologic Disease Response After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

Background (non-tumor bearing) liver tissue will be obtained by either biopsy or liver resection after combination chemoradiotherapy. Histologic markers of Radiation Induced Liver disease will be measured.

Number of Participants With Injury to the Background Liver After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

To determine the number of participants with Intrahepatic recurrence assessed by RECIST criteria using MRI of the abdomen with intravenous gadolinium contrast.

Four three-week treatment cycles. Gemcitabine (1000 gm/m^2) and cisplatin (25 mg/m^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.
Gemcitabine
Cisplatin
liver and portal lymph node low dose Radiotherapy

Number of Participants With Intrahepatic Recurrence After Partial Hepatectomy With Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

To determine the number of participants with Intrahepatic disease progression assessed by MRI of the abdomen with intravenous gadolinium contrast using RECIST criteria.

Number of Participants With Intrahepatic Disease Progression After Treatment With Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

Overall Study

Srinevas K. Reddy

Intrahepatic Cholangiocarcinoma

Gemcitabine

Whole liver and portal lymph node basin low dose radiotherapy

low dose radiotherapy

Virginia Piper Cancer Institute

Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC

A Phase 2 Study of Low-Dose Fractionated Radiation Therapy to the Whole Liver in Combination With Gemcitabine and Cisplatin in Locally Advanced Mass-Forming Intrahepatic Cholangiocarcinoma

Allina Health System

Patients were randomized to this arm will receive a bolus of N-acetylcysteine in an hour of 150 mg/kg after the beginning of the operation. After the bolus will start a 6-hour infusion of 50mg/kg/h of N-acetylcysteine.

Patients were randomized to this arm will receive a bolus of methylprednisolone in an hour of 500 mg after the beginning of the operation. After the bolus will start a 6-hour infusion of placebo (Ringer's acetate).

Patients were randomized to this arm will receive placebo (Ringer's acetate) in an hour after the beginning of the operation. After the bolus will start a 6-hour infusion of placebo (Ringer's acetate).

Ischemic Reperfusion Injury

Insufficiency; Hepatic, Postoperative

Liver Tumour

Methylprednisolone is a glucocorticoid, which is an adrenocortical steroid. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. It is an analog of naturally occurring glucocorticoid (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Methylprednisolone is used for their potent anti-inflammatory effects in disorders of many organ systems, it modify the body's immune responses to diverse stimuli. The usual dosage of medication varies in relation to pathology for which is prescribed: normally varies from about 40-60 mg per day up to very high doses of 30 mg/kg bolus as used in spinal cord injury.

Methylprednisolone

Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine. The compound is a white crystalline powder which melts at 104°-110°C and has a very slight odor. Acetylcysteine may form cysteine, disulfides, and conjugates in vivo (N, N'-diacetylcysteine, N-acetylcysteine- cysteine, N-acetylcysteine-glutathione, N-acetylcysteine-protein, etc). No metabolites were identified. Acetylcysteine likely protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.

N-acetylcysteine

Istituto Clinico Humanitas IRCCS

Methylprednisolone N Acetylcysteine in Hepatic Resections

Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections.

The primary endpoint of the study is the modulation of the IR injury made by NAC and/or MET in patients undergoing liver surgery. For this purpose a decrease of 100 UI/L of AST and ALT is expected compared with placebo.

This secondary endpoint want to assess difference in total bilirubin expression between the intervention groups and the placebo group.

This secondary endpoint want to assess difference in blood transfusion between the intervention groups and the placebo group.

cholangiocarcinoma/hypoxia

Abdominal Regional Perfusion in Donation After Cardiac Death for Multi-Organ Transplantation

Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma

Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC

Methylprednisolone N Acetylcysteine in Hepatic Resections

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