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NCT ID: NCT06345001 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma (HCC)

A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer

Start date: June 27, 2024
Phase: Phase 1
Study type: Interventional

Researchers are studying a new potential treatment for liver cancer. To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver. In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer. Researchers will use the following two forms of monoclonal antibody as study interventions during this study: - BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study. - BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study. In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies. The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will: - measure the amount of BAY3630942 radiation found in different organs over time. - measure the amount of BAY3630942 radiation absorbed by different organs. - use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment. Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions. The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day. Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes: - a visit up to 14 days before the start of the study to confirm if the participant can take part in the study. - up to 5 visits during the imaging intervention period. During this period, participants: - will receive the study interventions and have blood tests on the first visit, - will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit. - may have blood tests on the last visit. - a follow-up visit to check their health after 30 days of receiving the study interventions. During the study, the doctors and their study team will: - check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG) - track and study BAY3630942 using PET/CT imaging tests As the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required.

NCT ID: NCT06344052 Recruiting - Clinical trials for Basal Cell Carcinoma

To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

Start date: April 9, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy. Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms. - Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment. - Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment. - Arm 3 participants will receive daily hedgehog pathway inhibitor only.

NCT ID: NCT06342414 Recruiting - Clinical trials for Hepatocellular Carcinoma

An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer

ELUCIDATE
Start date: March 15, 2024
Phase:
Study type: Observational

It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.

NCT ID: NCT06342297 Recruiting - Clinical trials for Basal Cell Carcinoma

Dermatoscopy Guided Resection for Skin Cancer

Start date: January 14, 2024
Phase: N/A
Study type: Interventional

In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.

NCT ID: NCT06342167 Active, not recruiting - Radiotherapy Clinical Trials

Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma

Start date: March 14, 2024
Phase: Phase 2
Study type: Interventional

At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC). Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.

NCT ID: NCT06339619 Recruiting - Clinical trials for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma

Start date: March 11, 2024
Phase: Phase 2
Study type: Interventional

The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.

NCT ID: NCT06339424 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma

PhotonAB
Start date: March 29, 2024
Phase: Phase 2
Study type: Interventional

Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of 27%, the majority of patients face HCC progression and liver failure [Finn et al., N Engl J Med 2020]. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes. Radiation treatment (RT) is highly efficacious in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Importantly, a recent retrospective cohort described that RT combined with atezolizumab plus bevacizumab was associated with favorable median overall survival of 16.1 months (Manzar et al, Cancers 2022). Our preclinical study (Hsieh et al., Science Immunology 2022) revealed that RT combined with PD-L1/PD-1 blockade induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells, thereby potentiating the systemic antitumor T cell responses in murine tumor models. However, whether the combinatorial therapy with RT, atezolizumab, and bevacizumab can trigger synergistic antitumor effects and systemic immune mobilization has not yet been validated in clinical trials for unresectable HCC. Both atezolizumab/bevacizumab and X-ray RT are approved treatment methods for unresectable HCC by the U.S. and Taiwan Food and Drug Administration (FDA). The present phase II non-randomized trial aims to prospectively document the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with atezolizumab/bevacizumab combined with conventional photon radiotherapy.

NCT ID: NCT06339138 Recruiting - Clinical trials for Urothelial Carcinoma

Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing In Blood and Urine, The INQUIRE Study

Start date: February 20, 2018
Phase:
Study type: Observational

This study is being done to collect blood, tissue and urine samples to identify a novel high quality methylated DNA marker in patients with renal tumors.

NCT ID: NCT06337162 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)

HCC
Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant.

NCT ID: NCT06336187 Recruiting - Clinical trials for Renal Cell Carcinoma

European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study)

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

The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, <4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance. The primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression. The main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies. Then, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams. Follow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important.