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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT04555265 Completed - Clinical trials for Hepatocellular Carcinoma

Cytokine Change in Hepatocellular Carcinoma Treated by Thermal Ablation

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Background: Hepatocellular carcinoma (HCC) is the most common primary liver cancer with aggressive tumor behavior. Radiofrequency ablation (RFA) or microwave ablation (MWA) is an effective curative treatment for early stage HCC. This thermal ablation of liver tumor induces host immune response with changes in serum concentration of various cytokines. It is not clear whether this host immune response correlates with tumor recurrence and long-term patient survival. Objective: This prospective study is to investigate the change of cytokines' level following RFA or MWA for HCC and its clinical correlation with tumor recurrence and patients' long-term survival data. Hypothesis: Thermal ablation of HCC creates tumor antigen source for the generation of antitumor immunity and enhances host immune responses. The resulting inflammation and changes in cytokines may augment tumor cell death by increasing neutrophil infiltration and oxidative burst mechanisms. On the other hand, there may be negative effects via the production of growth factors, which could stimulate tumor cell growth within the sub-lethal margin. Therefore, the ultimate clinical consequences would be significantly affected by these immune responses. Study design: This is a prospective study on the measurement of changes of serum cytokines in patients with HCC undergone RFA or MWA using the commercially available kit (MILLIPEX, Human cytokine/chemokine magnetic bead panel - Immunology Multiplex Assay ), which measure 10 cytokines, including IL-1β, IL-6, IL-10, IL-12 (p40), IL-12 (p70), TNF-α, CXCL8, CXCL9, CXCL10, CCL2, CCL5. Statistical correlation will be performed between the cytokine change and long-term patients' clinical outcome using the prospectively collected database. Subjects: Patients with HCC undergone RFA or MWA in the Department of Surgery, The Chinese University of Hong Kong will be recruited. Exclusion criteria were evidence of extrahepatic metastasis, patients receiving combined hepatectomy and other local ablative therapy and patients with decompensated liver function that preclude local ablative treatment. Intervention: RFA or MWA will be performed for patients with HCC. The serum samples of all consecutive recruited patients will be collected prospectively during the intervention. The measurement of cytokines level will be performed in the Laboratory of Department of Chemical Pathology, The Chinese University of Hong Kong under the standard protocol. Main outcome measures: Primary outcome measure is early intrahepatic tumor recurrence within one year after thermal ablation. Secondary outcome measures are other tumor recurrence pattern (late intrahepatic recurrence and extrahepatic metastasis), overall survival and recurrence-free survival. Data analysis: All data will be prospectively collected by a research assistant and computerized in a database. Statistical analysis will be performed by Chi-square test or Fisher's exact test, where appropriate, to compare discrete variables and Mann-Whitney U test to compare continuous variables. Cumulative survival will be computed by the Kaplan-Meier method and compared by Log-rank test. Multivariable analysis using logistic regression model will be done to identify the independent prognostic factors affecting early tumor recurrence. Expected results: Understanding the relationship between the cytokines change during thermal ablation and post-treatment tumor recurrence helps to identify high risk patients for the possible adjuvant therapy in future study.

NCT ID: NCT04553458 Completed - Clinical trials for Hepatocellular Carcinoma

Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Start date: June 2015
Phase:
Study type: Observational

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

NCT ID: NCT04542837 Completed - HCC Clinical Trials

The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Start date: September 11, 2020
Phase: Phase 2
Study type: Interventional

This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.

NCT ID: NCT04510935 Completed - Clinical trials for Hepatocellular Carcinoma

Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro

Start date: August 20, 2020
Phase: N/A
Study type: Interventional

Numerous studies find that anesthetic methods may influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in the clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients randomized to receive either GA or LA during surgery, we will investigate the effects of anesthetic methods on cellular invasion, migration and proliferation of HepG2 hepatic cancer cells in vitro. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.

NCT ID: NCT04451603 Completed - Clinical trials for Hepatocellular Carcinoma

LiverMultiScan Analysis of MRI Scans in HCC

Start date: October 19, 2018
Phase:
Study type: Observational

This project is a pilot study to interrogate the potential of LMS as a predictive tool for the selection of therapy for HCC patients. The reliability of LMS to predict patients' response following HCC therapy will leverage on an algorithm that is built from the pool of MRI scans from HCC patients pre- and post-treatment. In the study, MRI scans of 30 HCC and metastatic colorectal cancer (CM) patients (ratio of 4:1) will be analysed. CM cancer patients include patients whose cancers metastasized from colorectal cancer or primary liver cancer. These patients will either receive one of the treatment, surgical resection, Y90 or systemic therapy. A total of 4 MRI scans will be taken for each patient; the first MRI scan will be taken within a month before treatment initiation and the remaining MRI scans will be taken at the 1st, 3rd and 9th month post-initiation of treatment.

NCT ID: NCT04444167 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

Start date: July 7, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

NCT ID: NCT04420026 Completed - Clinical trials for Hepatocellular Carcinoma

Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors

IAT
Start date: July 6, 2020
Phase: N/A
Study type: Interventional

The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.

NCT ID: NCT04415567 Completed - Clinical trials for Hepatocellular Carcinoma

Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation

Start date: June 1, 2018
Phase:
Study type: Observational

High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel targeted drug, has shown an excellent effect in the treatment of advanced HCC, but there is no study on its effect in preventing HCC recurrence in the patients undergoing transplantation. Therefore, to evaluate the role of adjuvant lenvatinib in preventing recurrence of high-risk LT recipients with HBV-related HCC, the investigators retrospectively analyzed 23 high-risk patients consisting of lenvatinib group (n=14) and control group (n=9) with HBV-related HCC who underwent LT. Disease-free survival (DFS) and HCC recurrence of the two groups were compared. The adverse events (AEs) and drug tolerance of lenvatinib were evaluated.

NCT ID: NCT04412161 Completed - Clinical trials for Hepatocellular Carcinoma

Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP

Start date: April 19, 2006
Phase:
Study type: Observational

Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with >6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP <200 ng/ml and GGT <104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.

NCT ID: NCT04401800 Completed - Clinical trials for Hepatocellular Carcinoma

Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Start date: September 4, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).