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Showing 1-20 of 49 trials
NCT07493668
This is a Phase 2, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of fostrox in combination with lenvatinib compared with lenvatinib alone in patients with locally advanced or unresectable advanced hepatocellular carcinoma (HCC) who have experienced radiologically confirmed disease progression following first-line combination immunotherapy. Approximately 80 patients will be enrolled at 9 study sites and randomized in a 1:1 ratio to 1 of 2 treatment arms: fostrox plus lenvatinib or lenvatinib alone. Patients assigned to the investigational arm will receive fostrox orally once daily on Days 1 through 5 of each 21-day cycle in combination with continuous daily lenvatinib. Patients assigned to the control arm will receive lenvatinib alone according to the approved weight-based dosing regimen. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The study population includes adult patients with locally advanced or unresectable metastatic HCC who have received at least 2 cycles of first-line systemic therapy with an immunotherapy combination and have radiologically confirmed disease progression. Eligible patients must have measurable disease according to RECIST version 1.1 and mRECIST, adequate organ function, and Child-Pugh class A liver function. The primary objective is to assess objective response rate (ORR) as determined by an Independent Review Facility (IRF) according to RECIST v1.1. Secondary objectives include evaluation of ORR by investigator assessment according to RECIST v1.1 and mRECIST, duration of response, disease control rate, progression-free survival, time to progression, overall survival, and safety and tolerability. Safety evaluations will include assessment of adverse events, serious adverse events, laboratory parameters, vital signs, and other clinical assessments. Exploratory objectives include evaluation of peripheral blood-based biomarkers, metabolic changes associated with study treatment, collection and storage of DNA and RNA for exploratory analyses, and pharmacokinetic assessment of fostrox and its metabolite troxacitabine in patients receiving fostrox in combination with lenvatinib. Tumor assessments will be performed at protocol-defined intervals using radiologic imaging. The primary efficacy analysis will be based on IRF assessment according to RECIST v1.1. This study is intended to characterize the clinical activity and safety profile of fostrox plus lenvatinib compared with lenvatinib alone in this patient population and to generate data to inform future clinical development.
NCT06040099
The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.
NCT07291076
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
NCT07365930
The NISTIPS TRITICC-4 study is a prospective, multicentre, non-interventional cohort study to analyze the effectiveness of transjugular intrahepatic portosystemic shunting (TIPS) in patients with Hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab as first-line treatment. It will further characterize the effectiveness of atezolizumab and bevacizumab therapy, investigate post-market safety and evaluate health-related quality in HCC patient cohorts with or without TIPS in a real-world setting.
NCT07380633
Toripalimab and bevacizumab (T-B) was approve for unresectable hepatocellular carcinoma (uHCC). Transartial therapies, including transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), and TACE-HAIC are commonly used for uHCC. Increasing evidence showed that combined systemic therapy and transarterial therapy will improve the response rate for those patients. It is unknown whether which tranarterial therapy will proved favorable efficiency when combined T-B. This phase 2 clinical trial aims to investigate the short outcome of T-B with three distinct transarterial therapies for uHCC.
NCT07368530
The goal of this observational study is to learn about the efficacy of Transarterial Chemoembolization (TACE) versus Hepatic Arterial Infusion Chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC). The main questions it aims to answer are: Can distinct imaging phenotype subtypes be identified in unresectable HCC patients using radiomics and unsupervised clustering? Do these different imaging subtypes show significant differences in treatment efficacy (such as objective response rate, progression-free survival, and overall survival) after receiving TACE or HAIC? Can this method objectively identify which imaging subtype of patients is more suitable for TACE and which may benefit more from HAIC? Participants in this study are adult patients diagnosed with unresectable HCC (BCLC stage B or C) who have already undergone complete TACE or HAIC treatment as part of their regular medical care between January 2015 and December 2024. Researchers will retrospectively analyze their existing clinical data and pre-treatment medical images to compare outcomes.
NCT07239986
This is a Phase 2 study to evaluate the efficacy and safety of BB102, a highly selective and potent FGFR4 inhibitor, as monotherapy in subjects with advanced or unresectable FGF19-overexpressing hepatocellular carcinoma. This study has two phase: dose escalation phase and expansion phase.
NCT03412773
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
NCT04687969
This research study wants to develop advanced imaging methods to more accurately characterize prostate cancer or solid tumor aggressiveness. This observational study involves \[18F\]DCFPyL positron emission tomography and magnetic resonance imaging (PET/MRI)
NCT06882876
This is an open-label, single-center, single-arm phase Ib clinical trial. The aim of this study is to assess the safety and efficacy of JS014 in combination with Toripalimab and transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC). The primary endpoint is the safety and tolerability, while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), time to progression (TPP), progression-free survival (PFS), and overall survival (OS).
NCT07156617
The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.
NCT07150624
A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hemihepatectomy for hepatocellular carcinoma were compared.
NCT07070076
The objective of this clinical trial is to compare the effects of yttrium-90 (SIRT) treatment and hepatic arterial perfusion chemotherapy (HAIC) on progression-free survival (PFS) in patients with potentially resectable HCC in the HCC population. The main questions it aims to answer are: * Whether yttrium-90 (SIRT) therapy is more effective than hepatic arterial infusion chemotherapy (HAIC) in treating patients with potentially resectable liver cancer * Whether yttrium-90 (SIRT) therapy is safer than hepatic arterial perfusion chemotherapy (HAIC) in patients with potentially resectable liver cancer The researchers compared yttrium-90 (SIRT) treatment to hepatic arterial perfusion chemotherapy (HAIC) to see if yttrium-90 (SIRT) was more effective in treating potentially resectable liver cancer. Participants will: * Patients will receive yttrium-90 (SIRT) therapy or 1 of them hepatic arterial perfusion chemotherapy (HAIC). * Follow-up at 1, 3, and 6 months after surgery * Keep a record of their symptoms and test results
NCT07138885
The goal of this prospective Phase II clinical trial is to evaluate the efficacy and safety of QL1706-based combination therapy in patients with hepatocellular carcinoma (HCC) who have failed prior targeted-immunotherapy (e.g., anti-PD-1/PD-L1 + antiangiogenic therapy). The main question is: Can the combination of localized-regional therapy (e.g., HAIC/TACE) and systemic dual immunotherapy (QL1706) overcome resistance and improve outcomes in second-line HCC treatment? Participants will: 1. Receive QL1706 (a dual immune checkpoint inhibitor) combined with either: Hepatic arterial infusion chemotherapy (HAIC)/transarterial chemoembolization (TACE), or Antiangiogenic targeted therapy. 2. Undergo regular imaging (e.g., MRI/CT) and biomarker assessments for efficacy monitoring. 3. Be evaluated for adverse events (AEs) and quality of life. This study seeks to establish a novel therapeutic paradigm for HCC patients after targeted-immunotherapy failure, addressing the unmet need for evidence-based second-line strategies.
NCT07047586
To evaluate the efficacy and safety of lenvatinib plus tislelizumab versus lenvatinib alone for patients with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.
NCT06999174
This prospective observational study investigates using multiparametric magnetic resonance imaging (MRI) to improve the characterization and management of therapy for hepatocellular carcinoma (HCC). The goal is to evaluate whether advanced MRI parameters can support noninvasive diagnostic assessments and personalized treatment plans for patients with HCC. The study is being conducted at a single university center in Germany and includes adult patients with confirmed or suspected HCC. Participants will undergo standardized multiparametric MRI examinations, and the imaging data will be correlated with clinical, pathological, and therapeutic outcomes. No study-specific interventions or medications will be administered.
NCT07030842
This retrospective observational study aims to evaluate whether artificial intelligence (AI) models can predict aggressive recurrence in patients who underwent liver resection for early-stage hepatocellular carcinoma (HCC). The main question it seeks to answer is: Can deep learning models combining preoperative MRI, postoperative pathology slides, and clinical data accurately identify HCC patients at high risk of aggressive recurrence after surgery? To answer this, the investigators will analyze existing medical data (preoperative MRIs, postoperative whole-slide images, and clinical records) from 579 patients across two medical centers. All data will be anonymized before analysis, and no additional interventions are required from participants. This study may help clinicians stratify high-risk patients who could benefit from closer surveillance or adjuvant therapies
NCT06990620
This study is a single-arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of Transarterial Chemoembolization (TACE) combined with envafolimab in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC), while exploring potential biomarkers associated with treatment response.
NCT06741020
Dear Sir/Madam, We would like to invite you to participate in this clinical research, which has been approved by the Medical Ethics Committee of Zhejiang Cancer Hospital. This informed consent form provides you with detailed information to help you decide whether or not to participate in this study. Please read it carefully, and ensure you fully understand it or get satisfactory answers to your questions before making your decision. If you have any questions, please feel free to consult the researchers, and we will provide you with comprehensive explanations. Hepatic artery infusion chemotherapy (HAIC) has recently become a popular local treatment method for liver cancer. A large Phase III clinical study from Sun Yat-sen University Cancer Center demonstrated that in a randomized comparison of HAIC versus transarterial chemoembolization (TACE) for unresectable large hepatocellular carcinoma (≥7 cm), the objective response rate (ORR) for HAIC was 46%, while TACE had an ORR of only 18%, with a statistically significant difference between the two. Additionally, HAIC showed advantages over TACE in terms of progression-free survival (PFS) and overall survival (OS), reducing the risk of disease progression by 43% and the risk of death by 42%. In subgroups based on age, sex, performance status, alpha-fetoprotein levels, tumor size, and number of tumors, HAIC consistently demonstrated superior PFS and OS. A study from Taiwan indicated that for patients with advanced liver cancer with portal vein tumor thrombus, the ORR for the HAIC group reached 22.86%, compared to 26.09% for those using immune checkpoint inhibitors alone, and an ORR of 50.00% for the group receiving HAIC combined with immune checkpoint inhibitors. FOLFOX (fluorouracil, leucovorin, and oxaliplatin) has shown positive results as a systemic treatment regimen for advanced liver cancer, with an ORR of 8.15%, a PFS of 2.93 months, and an OS of 6.47 months in comparative studies. When used as a treatment option in advanced liver cancer through hepatic artery infusion, its ORR increased to 31.5%, PFS to 7.8 months, and OS to 13.9 months. Common immune checkpoint inhibitors include PD-1 monoclonal antibodies and PD-L1 monoclonal antibodies. PD-1 antibodies prevent immune evasion by blocking PD-1 on immune cells, while PD-L1 antibodies block PD-L1 on tumor cells to inhibit their interaction, thus preventing immune evasion. Therefore, PD-1 monoclonal antibodies primarily target immune cells, while PD-L1 monoclonal antibodies primarily target tumor cells. This leads us to attempt hepatic artery infusion of PD-L1 monoclonal antibodies, utilizing a high-concentration saturation infusion method to maximally block PD-L1 on tumor cells and reduce tumor immune evasion. Concurrently, combining FOLFOX-HAIC localized chemotherapy leads to the release of tumor necrosis antigens, facilitating immune system activity. Thus, we aim to utilize hepatic artery infusion to deliver both PD-L1 monoclonal antibodies and chemotherapy into the liver, killing tumors with high concentrations of chemotherapy, which will lead to antigen release that aids subsequent immune drug effectiveness while reducing suppressive factors in the immune microenvironment, such as Tregs and M2 macrophages. This approach will help change the inhibitory status of the immune microenvironment and provide a foundation for subsequent immunotherapy. In BCLC staging, stage A patients and some stage B patients have resectable liver cancer. However, factors affecting tumor staging, such as maximum tumor diameter and tumor quantity, are also considered high-risk recurrence factors in clinical models. Therefore, later tumor staging itself is a high-risk factor for tumor recurrence. In 2009, Professor Mazzaferro and colleagues proposed the Up-to-Seven criteria (the sum of maximum tumor diameter and tumor number not exceeding 7). Patients who met this criteria and received liver transplantation had a five-year survival rate as high as 71%. Liver cancer patients exceeding the Up-to-Seven criteria are considered unsuitable candidates for liver transplantation, as exceeding this limit indicates a poor tumor biological behavior. Furthermore, the criteria align with the primary surgical treatment staging (CNLC Ia-IIa) recommended in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" published by China's National Health Commission. Therefore, we plan to conduct a neoadjuvant study targeting resectable liver cancer exceeding the Up-to-Seven criteria, using hepatic artery chemotherapy combined with immune checkpoint inhibitor (PD-L1 monoclonal antibody) infusion as the treatment regimen.
NCT06911255
Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma