View clinical trials related to Liver Metastasis Colon Cancer.
Filter by:Background: Removal of part of the liver (resection) is performed as a treatment for some cancers in the liver. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection) (1). Up to 30-50% patients develop recurrence within 2 years of surgery which could be due to incomplete removal of the cancer (2). Various techniques are used by the surgeons to identify the cancer tissue from the normal liver during the surgery so that it can be removed completely. These include examining with the naked eye, having a feel of the tumour, and performing an ultrasound scan. Even with these techniques it is difficult to identify the exact extent of the cancer. Also, the interpretation of the ultrasound scan can be subjective (3). A robust, objective, real-time navigation technique is required which can differentiate cancer from normal tissue. Indocyanine green (ICG) is a dye which when given through the veins, is taken up and retained by cancer cells in the liver and they appear as fluorescent areas as compared to normal liver which appears dark. This principle can be used to identify the cancerous tissue accurately during the surgery and remove it completely (Indocyanine green Fluorescence Image-Guided Surgery: I-FIGS). It can also potentially detect additional tumours which were not identified before the surgery or during the surgery with standard techniques (4,5). However, there is a lack of good quality evidence on the usefulness of I-FIGS in liver surgery, so this needs to be tested in a large group of patients having liver surgery before any recommendations can be made. Research Aim: This initial study aims to assess whether a larger trial evaluating the role of I-FIGS in complete removal of the cancer tissue is feasible. Investigators will assess if patients are willing to take part in the study and whether they can gather relevant clinical outcome data from them all. Investigators will also gather patients' views about this novel technique and participating in the study. Design and methods: This study will involve 40 patients having planned liver surgery for liver tumour/s recruited from University Hospitals, Plymouth. Patients will be randomly allocated to have I-FIGS plus standard surgery or standard liver surgery alone. Patients in the I-FIGS group will have ICG injection 2-4 hrs prior to surgery (0.03-0.05mg/kg dose) on the day of surgery. The surgical planning will be carried out as per the standard approach using the naked eye and intra-operative ultrasound examination. Once this is all recorded, ICG cameras will be switched on, and the additional findings and change to surgical plan will be noted. Focus groups will explore participants experiences of being in the study. This will inform the design of the future larger trial. Patient public involvement: Investigators have involved patients who have had or are having liver surgery in the development of the study. Their views on the technique, trial procedures and outcome measures have been incorporated. They will continue to be involved and advise on the study. Dissemination: Results will be available via research journals and conferences.
This will be a prospective, observational, cohort study to determine the impact of integrated diagnostics using quantitative magnetic resonance imaging, whole genome sequencing and digital pathology on intended patient management for liver cancer patients referred for liver resection. Participants with primary or secondary liver cancer will be recruited from Hampshire Hospitals NHS Foundation Trust in Basingstoke or Oxford University Hospitals NHSFoundation Trust in Oxford. The incidence of treatable liver tumours is on the rise globally, driven by obesity, viral hepatitis and metastases from colorectal cancers. Survival rates can be improved with optimised allocation of treatment options including surgical resection, radiofrequency ablation, embolisation, chemotherapy and targeted molecular therapies (including immunotherapy). The key motivation of this study is to help patients access the most suitable treatment combinations, based on integrating clinical, radiological and genomic data. A similar integrated approach, integrating radiology and pathology, has been shown to improve outcomes in breast cancer care. Detailed pathologic analysis of the surgical specimen from breast carcinoma biopsy provides valuable feedback to the radiologist, establishes the completeness of surgical intervention, and generates predictive information for therapeutic decisions. Whole genome sequencing (WGS) has discovered cancer driver mutations and the complex molecular profile of liver cancer. In many metastatic solid tumours, WGS has been used to identify a significant patient population (31%) who present with a biomarker that predicts sensitivity to a drug and lacked any known resistance biomarkers for the same drug. Identifying which patients possess druggable mutations will allow clinicians to make the optimal treatment decisions. The next challenge is integrating WGS into scalable clinical practice
This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128. The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations: - Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies - Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum) - Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease: - Patients in Cohort 1a will receive ATP128 as single agent - Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091 - Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091