Active clinical trials for "Liver Neoplasms"

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma (HCC) and other solid tumor types known for association with the MYC oncogene. The study consists of Part 1 (OTX-2002 monotherapy) and Part 2 (OTX-2002 combined with standard of care in hepatocellular carcinoma). Part 1 consists of escalation and expansion, and Part 2 consists of safety run-in and expansion. The objective of Part 1 escalation and Part 2 safety run-in will be safety and tolerability, while anti-tumor activity will be evaluated as the primary endpoint in Part 1 and Part 2 expansion.

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus regorafenib for patients with colorectal cancer liver metastasis in the third-line setting.

Evaluation of tislellimab combined with XELOX and bevacizumab or tislelizumab combined with FOLFOX and cetuximab regimen in patients with liver metastases from colorectal cancer Rate and R0 resection rate and safety.

PD-1 inhibitors have become the standard treatment for advanced hepatocellular cancer, while targeted drugs such as sorafenib and lenvatinib are the first-line standard treatment for hepatocellular cancer. Recent studies have shown that PD-1 inhibitors combined with targeted drugs can improve the efficacy of hepatocellular cancer.To clear the joint treatment in patients with advanced hepatocellular cancer (HCC) efficacy and evaluate its safety, we proposed to carry out the PD - 1 inhibitor (Toripalimab, JS001) joint anti-angiogenesis small molecules targeting drug anlotinib for clinical research,at the same time, based on joint solution of NGS platform testing to predict the curative effect, bring benefit for the long-term survival of patients with hepatocellular cancer (HCC).

The patients with non-resectable colorectal liver metastases (CRLM) have always being considered a particular subgroup of CRLM in which the therapeutic approach, is focused on strategies that allow a potential surgery like neoadjuvant systemic treatments. But, the underlying biology that causes this particular profile of spread in a proportion of patients that always recur and progress in the liver has not been properly characterized from a biological point of view. Unfortunately, these patients finally develop liver metastasis not amenable for local treatments and become refractory to systemic treatments even without developing extrahepatic liver metastases. As a result, liver transplantation (LT) is a potential for patients without extrahepatic involvement and nonresectable CRLM. There are several studies that aims to evaluate if LT increases overall survival compared to best alternative care. To our knowledge, none of these studies incorporate objectives focused on the underlying tumor biology of this particular population and the development of focused strategies including a dynamic disease monitoring and targeted treatments for this particular population.The METLIVER trial will permit to expand the genetic studies to the whole complexity of metastatic lesions and a more precise evaluation of their genetic heterogeneity. Moreover, it will help to precise the type of genetic analyses on liquid biopsies that can be designed for patients that will unfortunately relapse mostly with lung metastases after LT. Our proposal will maximize the opportunity to produce an unprecedented knowledge on CRLM evolution and will provide new opportunities for relapsed patients.

The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: Whole liver graft or partial liver (split) from a deceased donor Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT for unresectable CRLM. Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life. Donor selection is performed according to the currently used Institutional and National standards and protocols.

Over the past three decades, the treatment of both primary and secondary liver malignancies has been improved by the development and optimization of multiple minimally invasive thermal ablative therapies. These advances have resulted in a myriad of benefits for patients including decreased morbidity, mortality, as well as increased longevity and quality of life. However, these therapies can only be performed within certain parameters. Thermal ablative techniques such as radiofrequency ablation (RFA) and microwave ablation (MVA) are recommended for small lesions under 3 cm due to decreased efficacy when attempting to treat larger lesions. Additionally, large vessels in close proximity to a target lesion may result in heat dissipation, termed the "heat sink" effect, and result in incomplete ablation of the lesion. Furthermore, thermal ablative techniques cause off-target damage when utilized near sensitive structures such as the diaphragm, stomach, or bowel, and if performed near thermosensitive bile ducts, can result in cholestasis . Noting these limitations, percutaneous high-dose-rate brachytherapy was brought into clinical practice by Ricke et al. in Europe in 2002 . This therapy utilizes an iridium-192 (192Ir) isotope to administer a cytotoxic dose of radiation to a target lesion. It is not susceptible to heat sink effects and can also deliver radiation with the precision necessary to cause tumor death without destroying the integrity of neighboring structures. Additionally, it can be used to treat larger tumors (>3cm) as it is not associated the same size limitations as ablative techniques and can also be utilized to treat lesions that are not amenable to intra-arterial therapies (such as trans-arterial chemoembolization and yttrium-90 radioembolization). Since its inception, HDRBT has been evaluated through multiple studies investigating its use to treat lesions throughout the body including both primary and secondary liver malignancies such as hepatocellular carcinoma (HCC), cholangiocarcinoma, metastasis to the liver from colorectal cancer, pancreatic cancer , melanoma , and breast cancer . Its use in treating lymph node metastases has also been investigated . These studies have demonstrated the feasibility, safety, and clinical effectiveness of this method, establishing it as a therapeutic option when use of thermal ablation therapies is restricted. Most studies however, have been retrospective and have been performed outside the United States. Studying this therapy will add a crucial treatment option to our current armamentarium, filling a gap in currently available therapies and additionally allowing for further investigation of the use of HDRBT in a larger and more diverse population.

Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a new surgical procedure that induces rapid liver regeneration in patients with small liver remnant planning for major liver resection. It is a two-staged operation with stage I including portal vein ligation and splitting the right liver away from the left liver. After stage I, the left liver will undergo rapid liver regeneration and the stage II operation can be performed at 7-10 days after stage I operation when the liver remnant reaches an adequate size. In stage II operation, the right liver that contains the tumor is then removed. This surgical procedure was incepted in Germany in 2013 and was later started in Queen Mary Hospital in Hong Kong for the first time in December 2015. The initial indication was mainly for colorectal liver metastasis but due to the relatively high incidence of hepatocellular carcinoma in Hong Kong, HBP surgery team of Queen Mary Hospital has transferred this procedure to be applied for hepatitis-related hepatocellular carcinoma and so far, the centre has cumulated one of the largest single-center experience in the literature. Nonetheless, the usual approach for ALPPS involved open surgery and induced substantial surgical stress to the patient, especially after stage I operation. With the advent of minimally invasive liver surgery in recent years, the team has successfully applied laparoscopic surgery to ALPPS in 2019. Despite the advancement in laparoscopic surgical skills that rendered laparoscopic ALPPS feasible, there is scarcity of data in the literature to evaluate its outcome in comparison with open ALPPS with regard to perioperative recovery and liver regeneration. Hence, the aim of this project is to evaluate the short-term clinical outcomes of laparoscopic ALPPS and the impact of laparoscopy on liver remnant regeneration after ALPPS in a prospective randomised clinical trial setting.

This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent. Therefore, SBRT is being considered as a potentially curative procedure.