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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT04806243 Recruiting - Clinical trials for Hepatocellular Carcinoma

Carelizumab Combined With Regorafenib in the Treatment of HCC(CARE-2020)

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

NCT ID: NCT04803994 Recruiting - Clinical trials for Hepatocellular Carcinoma

The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

Start date: July 6, 2021
Phase: Phase 3
Study type: Interventional

The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.

NCT ID: NCT04803318 Recruiting - Clinical trials for Hepatocellular Carcinoma

Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors

Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.

NCT ID: NCT04803019 Recruiting - Clinical trials for Carcinoma, Hepatocellular

Transarterial Embolization Alone Versus Drug-Eluting Beads Chemoembolization for Hepatocellular Carcinoma

RAD-18-TAcE
Start date: December 4, 2019
Phase: Phase 3
Study type: Interventional

Developed in Japan in the 1980s, TACE became the most frequent treatment for unresectable hepatocellular carcinoma (HCC) in patients with preserved hepatic function after 2002, when two radiochemotherapies (RCTs) showed survival benefits for HCC patients who underwent conventional Lipiodol-based TACE (cTACE). Nowadays, nearly half of HCC patients undergo this procedure during their clinical history. In the last ten years, cTACE has been challenged by an alternative procedure, drug-eluting beads-TACE (DEB-TACE), after the introduction of calibrated embolizing microspheres loaded with a chemotherapeutic agent. DEB-TACE is considered to be less toxic and better standardized than cTACE, with reported no differences in patient survival. Since 2006, DEB-TACE has become the standard in many centers worldwide. Though, the need of adding doxorubicin to small beads embolization alone (TAE) remains unsettled. Though cTACE/DEB-TACE and TAE have been compared in several RCTs, no study demonstrated a clear survival benefit associated with the former. Our study aims to compare first-line DEB-TACE and TAE on a random sample of HCC with the hypothesis that the addition of drug to embolization with small size beads is not associated with a survival benefit when compared to embolization alone performed with tiny calibrated microspheres. HCC is considered a chemo-resistant tumor and to date there is no clear evidence of benefits in associating anticancer agents to TAE. On the other hand, the optimal size of embolic agents has still to be defined. A comparative evaluation of TACE and TAE is essential for two additional reasons: a) it is still unclear whether side effects following embolization procedures are related to the embolization itself, to drug addition or both; b) DEB-TACE procedure is more expensive than TAE and, given the current attention on cancer-related health care cost control, identification of opportunities for cost savings in HCC treatments of an increasingly common cancer would be valuable.

NCT ID: NCT04802954 Recruiting - Clinical trials for Hepatocellular Carcinoma

Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients

STARHE
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

By 2030, hepatocellular carcinoma (HCC) will become the second leading cause of cancer-related death, accounting for more than one million deaths per year according to the World Health Organization. To this date, screening for hepatocellular carcinoma in France remains uniform for all patients, based solely on a liver ultrasound every 6 months. This strategy has three main limitations: lack of personalisation, low compliance, relatively poor performance of the ultrasound. Risk stratification models have been developed for chronic hepatitis C, alcoholic cirrhosis and non-alcoholic steatohepatitis (NASH) including clinical and biological parameters but no analysis of the liver parenchyma which is the physiopathological substrate of hepatocarcinogenesis. The advent of new artificial intelligence techniques could revolutionize the approach and lead to a personalised radiological screening strategy. Deep learning, a subclass of machine learning, is a popular area of research that can help humans performing certain tasks by automatically identifying new image features not defined by humans. The hypothesis of this study is that the non-tumor cirrhotic liver parenchyma is rich in structural information reflecting the severity of the hepatopathy, its carcinological risk and the process of hepatocarcinogenesis. Its analysis combined with clinical and biological data, which have already been studied to stratify the risk of hepatocarcinogenesis, will allow to define a very high-risk population, particularly in the context of Hepatitis C Virus (HCV) eradication and Hepatitis B Virus (HBV) control. Consequently, this study proposes to design prospectively a deep learning model for stratification of the risk of hepatocarcinogenesis by including clinical, biological and radiological ultrasound parameters.

NCT ID: NCT04800497 Recruiting - Clinical trials for Hepatocellular Carcinoma

The Role Of Circulating Tumor Cells As Markers Of Advanced Disease And Prognosis In HCC

Start date: February 7, 2019
Phase:
Study type: Observational

Hepatocellular carcinoma (HCC) recurs in up to 60% of patients who undergo resection. Circulating tumor cells (CTC) have been advocated as promotors of the recurrence. However, their role as prognostic markers in the surgical setting is unclear. The aim of the present study has been to assess the association between CTC from peripheral blood samples and the risk of recurrence after surgery. Patients with a first diagnosis of HCC, no previous treatment for this condition, no other oncological history, and BCLC stage 0-A-B will be enrolled in 2 centers. Patients will undergo to serial liquid biopsies (i.e., a 15ml peripheral blood sample on each time point) at day 0-30-90-180-365 after surgery. After isolation of peripheral blood mononucleate cells, CTC will be detected by FACSymphony™ and subsequently the following markers will be identified: EpCAM, N-cadherin (N-cad) and CD90. Epithelial-mesenchymal transition (EMT) will be analyzed by an index estimated as the ratio between the number of EpCAM+/N-cad- and EpCAM+/N-cad+ cells (EMT Index). Patients will be divided according to the recurrence status.

NCT ID: NCT04797884 Recruiting - Clinical trials for Hepatocellular Carcinoma

Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma

ARTEMIS
Start date: July 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.

NCT ID: NCT04796025 Recruiting - Clinical trials for Hepatocellular Carcinoma

TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study

T-Double
Start date: September 23, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with pd-1 antibody immunotherapy (Sintilimab) and anti-VEGF (Bevacizumab Biosimilar) in patients with advanced hepatocellular carcinoma (BCLC-C Stage).

NCT ID: NCT04792801 Recruiting - Clinical trials for Hepatocellular Carcinoma

PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC

TEP CARE
Start date: June 22, 2021
Phase:
Study type: Observational

HCC is the most common malignant liver tumor for which liver transplantation is one of the pivotal curative treatments. The best possible selection of patients who are candidates for transplantation is essential in the current context of a shortage of transplants. Performing a PET CT scan is not currently recommended in the pre-liver transplant workup for HCC. However, PET CT using in a complementary manner the FDG and Choline tracers appears promising in the management of HCC in view of its wide use in oncology and its major diagnostic and prognostic contribution compared to conventional imaging. In order to address this issue, a prospective cohort study including patients from the University Hospital of Rouen and Lille with hepatocellular carcinoma meeting the criteria for indication of liver transplantation validated in SPC will be set up, the main objective of which will be to assess the decision-making contribution of PET TDM FDG and Choline in addition to conventional imaging in the pre-transplant assessment.

NCT ID: NCT04791735 Recruiting - Clinical trials for Hepatocellular Carcinoma

Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma

LapCHC
Start date: May 21, 2021
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients. Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization