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NCT06045975
This project is a Phase 2 trial testing the safety and efficacy of treatment with Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting in patients with BCLC A HCC treated by by percutaneous ablation (PA) procedure in a curative intent. DUMELEP is a Multicentre, Phase 2 trial Eligible patients will receive consecutively: 1. 1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting 2. percutaneous ablation procedure in a curative attempt at Day 30 3. 11 monthly Durvalumab 1500 mg infusions. 4. Classical follow-up during an additional year (every 3 months)
NCT07495735
This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.
NCT05665348
TRIPLET HCC is a phase II-III trial that assess the effectivness of addition of ipilimumab to the combination atezolizumab-bevacizumab, on global survival and response to the treatment, for patients with advanced or metastatic hepatocellular carcinoma. The theoretical duration of the study is 5 years. In the scope of this study, each patient will have 2 years of treatment and 2 years of follow-up from their enrollment date.
NCT07412054
The goal of this clinical trial is to learn whether adding branched-chain amino acids (BCAAs) to lenvatinib and pembrolizumab improves treatment outcomes in adults with unresectable hepatocellular carcinoma (HCC). The study will also evaluate the safety of this combination treatment. The main questions this study aims to answer are: Does the addition of BCAAs improve the time patients live without their cancer getting worse? Does the combination treatment improve tumor response compared with standard treatment alone? What medical problems or side effects do participants experience during treatment? Researchers will compare lenvatinib plus pembrolizumab with BCAAs to lenvatinib plus pembrolizumab alone to see whether adding BCAAs provides additional benefit for patients with unresectable HCC. Participants will: Be randomly assigned to receive lenvatinib and pembrolizumab with or without oral BCAAs Take lenvatinib by mouth every day and receive pembrolizumab by intravenous infusion every 3 weeks Continue treatment until disease progression, unacceptable side effects, or withdrawal from the study Visit the clinic regularly for physical examinations, imaging tests, blood tests, and safety assessments
NCT07363512
For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows: First, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).
NCT07306481
On the basis of previous studies, this study intends to explore the efficacy of preoperative oral administration of Lactobacillus reuteri (Lr) combined with preoperative neoadjuvant/conversion therapy in patients with primary resectable hepatocellular carcinoma (HCC). We hypothesize that this combination represents a novel, microbiota-based therapeutic strategy to facilitate perioperative hepatic recovery and improve long-term survival outcomes. This study is an open-label, randomized, blank-controlled clinical trial. Patients undergoing liver resection were randomly allocated to one of two groups. The intervention group received preoperative oral Lactobacillus reuteri (Lr) supplementation alongside neoadjuvant/conversion immunotherapy. The control group received preoperative neoadjuvant/conversion immunotherapy alone. Fecal and peripheral blood samples will be collected at baseline (pre-medication), 3 days prior to surgery, and at 5 days, 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Intraoperative liver tissue samples will also be obtained. Statistical analyses will be performed to compare intergroup differences in postoperative liver function recovery, overall survival, hepatic and peripheral immune markers, and gut microbiota composition. This study aims to develop adjuvant strategies to enhance therapeutic outcomes for HCC patients undergoing preoperative neoadjuvant/conversion immunotherapy.
NCT07285850
This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.
NCT07106827
This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg/kg and 20 mg/kg dose groups, respectively. The cancer types include solid tumors.
NCT07230080
The goal of this clinical trial is to evaluate whether sequential transarterial chemoembolization (TACE) followed by stereotactic body radiotherapy (SBRT) combined with targeted immunotherapy is effective and safe for patients with intermediate to advanced hepatocellular carcinoma (HCC) who are not eligible for curative treatment such as surgery or liver transplantation. This is a single-center, single-arm, retrospective study. All participants included in the analysis will have received the combined treatment regimen. The main question the study aims to answer is: Can sequential TACE-SBRT combined with targeted immunotherapy improve the objective response rate (ORR) in patients with intermediate to advanced HCC? Interventions Participants in this study have undergone the following treatments: TACE: a minimally invasive procedure to block the blood supply to the tumor while delivering chemotherapy directly. SBRT: a highly precise form of radiation therapy targeting the liver tumor. Targeted immunotherapy: systemic treatment that stimulates the immune system to recognize and attack cancer cells. Participant Population The study includes adult patients diagnosed with intermediate to advanced HCC who were not candidates for curative resection or transplantation.
NCT06999837
The purpose of this study is to evaluate the use of multiparametric dynamic whole-body \[68Ga\]Ga-PSMA PET/CT imaging in newly diagnosed HCC patients or in HCC patients with recent suspicion of refractory, residual, or recurrent disease.
NCT07184424
This study is a real-world, single-arm, observational study primarily collecting data on patients with hepatocellular carcinoma who experienced disease progression after receiving lenvatinib in combination with PD-1 inhibitors as part of routine clinical practice, and evaluating the efficacy of adding lenalidomide to their treatment regimen.
NCT07141056
The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.
NCT07132515
We will give an anticoagulant against portal vein thrombosis, and watch for the results.
NCT07097870
This study aims to identify clinical and laboratory factors that predict the occurrence of hepatocellular carcinoma (HCC) in Egyptian cirrhotic patients after achieving a sustained virologic response (SVR) to hepatitis C virus (HCV) treatment. This is a retrospective, two-center, case-control study that will include 132 cases and 264 controls. Variables to be analyzed include demographics, liver disease status, metabolic comorbidities, lifestyle factors, medications, as well as laboratory parameters and non-invasive scoring systems.
NCT07088081
This study aims to evaluate the response to immunotherapy in HCC, assess the toxicity profile and measure overall survival within the study period. The primary end point is evaluation of progression free survival in HCC patients receiving immunotherapy. The secondary end point is to assess overall survival within the study period, duration of response and the response rate. The tertiary end point is to assess the toxicity profile.
NCT06999707
Tremelimumab plus durvalumab (the STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC); however, it demonstrates limited efficacy, with an objective response rate (ORR) of only 20.1%. Radiation therapy (RT) is highly effective in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Preclinical studies have shown that combining RT with PD-L1/PD-1 blockade promotes immunogenic cell death and enhances antigen presentation by dendritic cells, thereby boosting systemic T cell-mediated antitumor responses in mouse models. The addition of CTLA-4 inhibition further enhances antigen cross-priming following RT. Recent retrospective data also indicate that combining RT with immune-oncology agents is associated with improved overall survival and prolonged time to progression compared to RT or immunotherapy alone. However, the clinical benefit and immunologic impact of combining RT with tremelimumab and durvalumab have not yet been evaluated in prospective clinical trials for unresectable HCC. This phase II, single-arm clinical trial aims to assess the safety, efficacy, and immunologic effects of combining proton RT with tremelimumab and durvalumab in patients with unresectable HCC.
NCT06958484
Evaluation of the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) in combination with bevacizumab for postoperative adjuvant treatment of HCC with high-risk recurrence risk
NCT06883539
A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor. Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected. The main questions it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection 2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection
NCT06760494
An artificial intelligence (AI) model to predict MVI of HCC using contrast-enhanced ultrasound was constructed. This model also has biological explainability. The investigators named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability). The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China.