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Liver Metastasis clinical trials

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NCT ID: NCT03801915 Completed - Pancreatic Cancer Clinical Trials

Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers

Start date: November 13, 2019
Phase: Phase 2
Study type: Interventional

Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease. Objective: To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease. Eligibility: Adults at least 18 years old with certain cancers and certain blood CA19-9 levels Design: Participants will be screened with: - Medical history - Physical exam - Blood and heart tests - Scans - Review of normal activities - Review of tumor sample - Pregnancy test A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours. Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research. For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay. After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.

NCT ID: NCT03785210 Completed - Clinical trials for Hepatocellular Carcinoma

Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers

Start date: June 5, 2019
Phase: Phase 2
Study type: Interventional

Background: A most common liver cancer in adults is hepatocellular carcinoma. Other kinds of liver cancer happen when colorectal or pancreatic cancer spreads to the liver. Researchers want to study if a combination of drugs helps people with these cancers. The drugs are nivolumab, tadalafil, and vancomycin. Objective: To investigate if nivolumab given with tadalafil and vancomycin causes liver cancer to shrink. Eligibility: Adults ages 18 years and older with hepatocellular carcinoma or metastases to the liver from colorectal or pancreatic cancer for which standard treatment has not worked Design: Participants will be screened with: Medical and cancer history Review of symptoms and ability to perform normal activities Physical exam Heart test. Some participants may meet with a cardiologist and/or have another heart test. Scan of the chest, abdomen, and pelvis Blood and urine tests Tumor sample review. This can be from a previous procedure. Participants will receive the study drugs in 4-week cycles. In each cycle participants will: Get nivolumab through a small plastic tube in the arm on Day 1. Take tadalafil by mouth 1 time every day. Take vancomycin by mouth 4 times a day. They will take it every day for weeks 1 3, then not take it for week 4. Complete a medicine diary of dates, times, missed doses and symptoms. Throughout the study, participants will repeat screening tests and will give stool samples or rectal swabs. After their last cycle, participants will have 3 follow-up visits over 3 months. Then they will be contacted every 6 months by phone or email and asked about their general well-being. ...

NCT ID: NCT02316028 Completed - Colorectal Cancer Clinical Trials

Phase I:Decitabine by Hepatic Arterial Infusion(HAI) in Unresectable Liver Metastases Colorectal Cancer (CRC)

DECIT
Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Despite the advances in the medical treatment of unresectable liver metastases from colorectal cancer there is currently no curative treatment option available for these patients. Decitabine is a cytidine analog with proven anti-neoplastic activity in patients with acute myeloid leukemia and myelodysplastic syndromes. Decitabine causes demethylation of the DNA strands of replicating cells. Hereby decitabine treatment demethylates the promoter regions of tumor suppressor- and cancer testis antigen encoding genes leading to expression of these genes by the cancer cells. The hepatic arterial route for administration of cytotoxic drugs has been widely explored in treatment of colorectal cancer liver metastases because these metastases depend for their blood flow from this artery (as opposed to the normal liver tissue that is mainly dependent from the portal vein). By investigating the administration of decitabine by hepatic arterial infusion the investigators intend to explore the potential advantage of minimizing the systemic exposure (and toxicity) and maximizing the concentration of decitabine within the liver metastasis. The primary objective of this phase I will be to establish the recommended dose for decitabine by HAI for further use in phase II trials. The most important secondary objective will be to document the effect of decitabine by HAI on the expression of cancer testis antigens by the colorectal cancer cells, serving as a reference for potential further exploration of decitabine by HAI in combination with cancer immunotherapy

NCT ID: NCT02218801 Completed - Clinical trials for Colorectal Carcinoma

A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program

CLIMB
Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

This prospective database has two main objectives; - to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer. - to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.

NCT ID: NCT01834014 Completed - Colorectal Cancer Clinical Trials

Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases

ATOM ES
Start date: May 2013
Phase: N/A
Study type: Interventional

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

NCT ID: NCT01785212 Completed - Liver Neoplasms Clinical Trials

The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver

Start date: March 2013
Phase: N/A
Study type: Interventional

The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic resection in our center. Recently a stapler-hepatectomy methods has been developed and approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this method is a potential shorter transection time compared to the CUSA technique. Thus the investigators will perform a randomized controlled trial including 20 patients in the stapler-group and 20 patients in the CUSA control group. Primary endpoint will be transection speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines concentration, T cell subsets, blood loss, morbidity, and a cost analysis.

NCT ID: NCT01632722 Completed - Colorectal Cancer Clinical Trials

Perioperative vs Postoperative Chemotherapy + Bevacizumab in Colorectal Cancer, Liver Mets

Start date: June 2012
Phase: Phase 2
Study type: Interventional

Early-stage colorectal cancer(CRC)is localized and resectable, but 20% of the patients have metastatic disease at the time of diagnosis and 50% of all patients eventually die of the disease. The most frequent site of colorectal metastases is the liver, which accounts for 30% to 60% of cases. In these patients, the extent of liver disease is the main determinant of survival. Hepatectomy is the only potentially curative therapy for colorectal liver metastases (CLM), but when traditional criteria for resectability were used, only 10% of patients were candidates for surgical resection. Although adjuvant systemic therapy after resection of primary colorectal tumors is well established, there are relatively few data on the use of postoperative therapy vs. surgery alone in patients who have undergone resection of liver metastases. In this trial, the absolute increase in the 3-year PFS rate with the addition of FOLFOX4 was a modest but significant 9% in patients who had resection (from 33% to 42%; P = .025). For improving survival in patients with CLM, several studies with biologic agents have been tried. The use of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), has resulted in increased response rates in patients with stage IV colorectal cancer and improved OS and PFS. In an ongoing phase II trial presented in ASCO 2008, in patients who were potentially curable through resection of liver metastases, perioperative treatment with capecitabine and oxaliplatin (XELOX) plus bevacizumab yielded an overall response rate of 73% with stable disease in 21% and a mean PFS of 27 months. Response to chemotherapy significantly correlated with a prolonged PFS (P < .001). On the basis of these backgrounds, we designed a phase II study to compare the effectiveness of combination chemotherapy with perioperative or postoperative bevacizumab treatment in patients with CLM.

NCT ID: NCT01031784 Completed - Liver Metastasis Clinical Trials

Radioactive Holmium Microspheres for the Treatment of Liver Metastases

HEPAR
Start date: December 2009
Phase: Phase 1
Study type: Interventional

The HEPAR study is aimed at determining the safety of radioactive holmium containing microspheres for the treatment of tumors in the liver. These microspheres will be administered by infusion in the liver artery using a arterial catheter in the femoral artery.

NCT ID: NCT00914615 Completed - Liver Metastasis Clinical Trials

Stereotactic Body Radiation Therapy (SBRT) in Liver Metastasis (COLD 3)

Start date: August 2007
Phase: Phase 2
Study type: Interventional

This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life. SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. Presently, the treatment for unresectable liver metastases from colorectal cancer is most often chemotherapy or novel targeted therapy. These treatments may improve survival, but not control the metastases permanently; so new treatments are needed to control metastases. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.

NCT ID: NCT00892424 Completed - Cancer Clinical Trials

Sorafenib-RT Treatment for Liver Metastasis (SLIM)

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Cancers that have spread to the liver from the primary cancer location (liver metastases) that cannot be removed surgically (unresectable) can be treated with chemotherapy and/or radiation therapy. Previous research has shown that tumours often have abnormal blood vessels that may reduce the effect of radiation therapy. New drugs, known as "anti-angiogenic" drugs have been shown in animal and human studies to damage or change tumour blood vessels in ways that may make tumors more sensitive to radiation treatment. 32- 44 Patients diagnosed with unresectable liver metastasis will be invited to take part in this study. The purpose of this study is to investigate the use of a new anti-angiogenic drug called Sorafenib, in combination radiation therapy and chemotherapy. The study will test how effective the new treatment is, the side effects associated with the new treatment, and to help establish safe dosages of the study medication.