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Liver Neoplasms

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Gastrointestinal Diseases

Liver Diseases

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All Drugs and Chemicals

Liver Extracts

Single dose of yttrium-90 carbon microspheres injection. Patients will be assessed by SPECT-CT imaging within 24 hours for yttrium-90 distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available).

Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres

Hai-Dong Zhu, MD

Gaojun Teng, MD

Gao-Jun Teng, MD

To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases

The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases remain unknown. This multicentre, prospective, open-label, single-arm trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases. The primary endpoints are the progression-free survival rates of liver target lesions. While the secondary endpoints include the safety, tumor control, and the distribution characteristics of yttrium-90 carbon microspheres.

Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases

Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases: A Multicentre, Prospective, Open-label, Single-arm Trial

Survival probability of patients without imaging progression of liver target lesions

Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available)

Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)

Time without imaging progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)

Time without imaging progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)

Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)

Zhongda Hospital

Dean

Micronutrients

Antineoplastic Agents

Leucovorin

Oxaliplatin

Subjects who are planning to undergo surgery for placement of HAI therapy pump will be considered for enrollment. Standard HAI therapy requires a laparotomy and placement of an intrahepatic arterial catheter that is connected to one of several commercially available subcutaneous electronic pumps. The pump is then used to deliver FUDR and Leucovorin directly to the liver, usually beginning four weeks after surgery and lasts on average for a period of six to twelve months after the study. This study will examine the addition of a one hour isolated hepatic perfusion with oxaliplatin to this standard treatment

The starting dose of oxaliplatin administered via isolated hepatic perfusion will be the safe tolerated dose of intra-arterial infusion and pharmacokinetics from intravenous studies. The dose will be 5 mg/m2 and will be escalated.

David L Bartlett, M.D.

The primary goal of this research study is to determine a safe dose for the drug oxaliplatin when delivered by isolated hepatic perfusion. The second goal of this research study is to determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard hepatic arterial infusional (HAI) therapy with floxuridine (FUDR)/leucovorin.

Isolated Liver Perfusion With Oxaliplatin

A Phase I Trial of Isolated Hepatic Perfusion With Oxaliplatin Followed by Hepatic Arterial Infusion of FUDR and Leucovorin for Patients With Unresectable Colorectal Liver Metastases

The Pittsburgh Foundation

Sanofi

David Bartlett

Professor of Surgery

Carcinoma

Carcinoma, Hepatocellular

Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by the Liver transplantation team. Patients must demonstrate favorable tumor biology and no evidence of extra hepatic disease.

Liver transplantation

Roberto Hernandez-Alejandro, MD

Jennie Errigo

Matthew Byrne, MD

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.

After explant of the native liver, patients will be enrolled in a biorepository with planned collection of snap frozen tissue and plasma and formalin fixed and paraffin embedded samples.

Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

Liver Transplantation From Living Donors For Treatment Of Non-Resectable Colorectal Carcinoma Liver Metastases: A Registry Study

RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

University of Rochester

Professor

Cornelius A Thiels

Cornelius Thiels, DO, MBA

The purpose of this study is to evaluate the surgical outcomes and the quality of life (QOL) in patients undergoing hepatic artery infusion pump placement for colorectal liver metastases (CRLM).

Patient Outcomes After Hepatic Artery Infusion Pump Placement

Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement

Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

Number of days following hepatic artery infusion pump placement until chemotherapy is started

Complications with hepatic artery infusion pump placement

Complications with hepatic artery infusion chemotherapy

Mayo Clinic

Principal Investigator

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Bevacizumab

Cetuximab

Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

Chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

chemotherapy ± targeted therapy

Jianmin Xu, Ph.D., M.D

To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.

Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.

New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases

Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases

Time from randomization to the date of disease progression or to death of any cause

Time from randomization to death from any cause or the date of the last follow-up

The rate of patients converted to resection for liver metastases

The proportion of patients with any complications occurred within 30 days after surgery

Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases	NCT05692037	Unresectable Co...	Selective inter...	18 Years - 80 Years	Zhongda Hospital
Isolated Liver Perfusion With Oxaliplatin	NCT01042691	Unresectable Co...	Oxaliplatin	18 Years -	University of Pittsburgh
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases	NCT05248581	Colorectal Canc...	Liver transplan...	18 Years -	University of Rochester
Patient Outcomes After Hepatic Artery Infusion Pump Placement	NCT05468593	Colorectal Live... Colorectal Canc...		18 Years -	Mayo Clinic
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases	NCT05248581	Colorectal Canc...	Liver transplan...	18 Years -	University of Rochester
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases	NCT05692037	Unresectable Co...	Selective inter...	18 Years - 80 Years	Zhongda Hospital
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases	NCT05248581	Colorectal Canc...	Liver transplan...	18 Years -	University of Rochester
New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases	NCT01307878	Colorectal Neop... Neoplasm Metast... Liver Neoplasms Chemotherapy; M...	chemotherapy ± ...	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for unresectable colorectal liver metastases