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Liver Neoplasms clinical trials

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NCT ID: NCT06084234 Recruiting - Hepatitis B Clinical Trials

National Liver Cancer Screening Trial

TRACER
Start date: December 26, 2023
Phase: Phase 4
Study type: Interventional

The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.

NCT ID: NCT06071052 Not yet recruiting - Clinical trials for Liver Metastasis Colon Cancer

TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Liver metastasis is the main reason that affects the survival rates of patients with colorectal cancer (CRLM), and is also the main cause of death of those patients. Especially after the failure of first-line or second-line system treatment, the prognosis of those patients is extremely poor, with the median OS of only 3.5 months. Even in combination with molecular targeted drugs such as cetuximab or bevacizumab, the median tumor-free survival period is only 4.8-6.8 months, and OS is only 11-15 months. When they have disease progression, treatment is currently a difficult clinical problem. Regofinib is a new targeted drug for the third-line treatment of advanced colorectal cancer in recent years. However, in the prospective multicenter clinical study, compared with the placebo group, the extended OS is only 1.4 months, which is not so satisfactory. How to improve the survival of these advanced patients with drug resistance is an important clinical problem to be solved urgently. Minimally invasive local treatment may be a promising way to solve this problem. Transcatheter arterial chemoembolization (TACE) and hepatic artery infusion chemotherapy (HAIC) are currently the most widely used methods in clinical practice. In theory, TACE combined with HAIC can control small metastasis and embolic residual lesions. The combination of TACE and HAIC can improve the curative effect. Whether the combination of TACE, HAIC and Regofinib can be expected to achieve the effect of 1+1+1>3 in CRLM patients who have failed the previous second-line chemotherapy remains unknown. Therefore, the purpose of this study is to explore the safety and clinical efficacy of irinotecan-loaded drug-eluting beads-TACE (DEBIRI-TACE) combined with HAIC and Regofinib in the treatment of patients with CRLM who failed standard treatment regimens.

NCT ID: NCT06069960 Not yet recruiting - Clinical trials for Colon Cancer Liver Metastases

SALT for Unresectable Colorectal Liver Metastases

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

Colon cancer is a common malignancy with a low survival rate worldwide, and unresectable colon cancer liver metastases (ICRLM) have a worse prognosis. The liver is the most common metastatic organ of colorectal cancer, and palliative chemotherapy is the only option for most ICRLM patients. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%. Liver transplantation is an ideal choice for patients with ICRLM, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of iCRLM. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.

NCT ID: NCT06059885 Recruiting - Liver Neoplasms Clinical Trials

Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC

Start date: December 22, 2021
Phase: Phase 2
Study type: Interventional

Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.

NCT ID: NCT06050200 Not yet recruiting - Liver Cancer Clinical Trials

TANGO-LIVER Three Arm Nuclear Growth Observation in Liver Surgery

TANGO-LIVER
Start date: May 2024
Phase: N/A
Study type: Interventional

Liver resection is the treatment of choice in patients with malignant liver lesions. Unfortunately, the surgery is not always an option, as in same patients the future remnant liver (FRL) is too small to supply all the functions. Therefore, some additional methods have been proposed to increase the size of the FRL. The aim of this study is to compare the efficacy and safety of three methods of increasing the future remnant liver - Portal Vein Embolization (PVE) - embolization of one of the portal branches; Liver Vein Deprivation (LVD) - embolization both of the portal branch as well as the hepatic vein; and partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection. The efficacy of those three methods will be assessed both by analyzing the volumetric increase (by computer tomography scans) and by functional increase (by 99mTc-mebrofenin scintigraphy). Functional assessment of the liver hypertrophy seems to be of crucial importance, as some of the previous studies suggest that there might be a significant discrepancy in the increase of size comparing to the increase of function. This is a prospective, interventional randomized study. The study group (154 patients) will consist of patients being considered as candidates for major hepatic resection, after inducing hypertrophy of the future remnant liver. The primary study hypothesis is greater efficacy of ALPPS in preparing patients for large hepatic resection by inducing hypertrophy of the future remnant liver, as compared both to PVE and LVD. In case of unsuccessful induction of hypertrophy by the embolization techniques, patients may be qualified to rescue ALPPS procedure. Primary end-point: Percentage of patients with successful resection (patients, who gained sufficient increase of the FRL to proceed to the liver resection) with no post-surgical 90-day mortality. Secondary end-points: 1. the rate and degree of volume increase in different groups 2. the rate and degree of functional increase in different groups 3. CCI index and complication rate >=3 degree according to the Clavien-Dindo classification after the first stage of treatment 4. CCI index and complication rate >=3 degree according to the Clavien-Dindo classification after the second stage of treatment 5. overall duration of hospital stay Patient will be randomly assigned to the three study groups. All patients will undergo an abdominal contrast enhanced computed tomography and 99mTc-mebrofenin scintigraphy prior to the first stage of treatment. During the first stage of treatment, patients will undergo, according to their group: 1. Embolization of portal vein branch (PVE, portal vein embolization) 2. Embolization of both portal vein branch and hepatic vein (LVD, liver venous deprivation) 3. Partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection, preferentially by laparoscopic technique Computed tomography scans and scintigraphy will be repeated at day 7, 14 and 21 after the first stage of treatment. The second stage of treatment, the liver resection, will be performed after achievement of sufficient mebrofenin clearance rate (>=2,69%/min/m2). In case of failure to reach the desired clearance rate, the measurements will be continued every 7 days up to day 42. In case of uncertainty and discrepancy between the volumetric assessment in the computed tomography scan and the mebrofenin scintigraphy, it will be allowed to proceed to stage two (partial hepatectomy) after joint consultation of at least 3 hepatobiliary surgeons, 1 radiologist and 1 nuclear medicine specialist. Routine blood tests will be performed according to the standard procedure in the Department, depending on the patient clinical status. An additional blood sample will be collected from patients (after receiving and additional informed consent from the patient) and will be stored in the biobank. All patients will be monitored for surgical and 90-day complications. The volume increase after first stage of treatment, the functional increase after first stage of treatment, percentage of patients successfully proceeding to the second stage of treatment and complication rate will be calculated. The percentage of patients with complications >= 3 degree in Clavien-Dindo classification and CCI index for each patient will be calculated. Furthermore, the blood test results will be assessed to search for associations with patients' outcomes. Any possible differences in terms of baseline patients characteristics between groups will be addressed. Statistical analysis will be performed using U Mann-Whitney test, exact Fisher's test, logistic regression, general linear models, Kaplan-Meier method and log-rank test. All three groups will be assessed in terms of occurrence of primary and secondary end-points.

NCT ID: NCT06038552 Completed - Liver Metastases Clinical Trials

The Long-term Efficacy of Imatinib With Hepatic Resection or Other Local Treatment for GIST Liver Metastases

Start date: January 1, 2002
Phase:
Study type: Observational

The goal of this observational study is to evaluate the overall survival benefits of local treatment combined with imatinib(IM) and IM alone in patients suffering from GIST liver metastases. The main question it aims to answer is: • Whether IM combined with hepatic resection (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE) has better long-term survival benefits compared to IM monotherapy. Patients are divided into different treatment groups: - IM group - IM combined with HR group - IM combined with RFA or TACE group Researchers will compare the IM + HR group and IM + RFA/TACE group with the IM group to see if it has a better Overall survival (OS).

NCT ID: NCT06031129 Completed - Visceral Pain Clinical Trials

Butorphanol in Pain Following Ablation for Hepatic Tumor

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The objective of this investigation was to evaluate the influence of Butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. Employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either Butorphanol (experimental group) or normal saline (control group). Primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the 6-hour mark (VAS) and comprehensive pain assessment outcomes.

NCT ID: NCT06021015 Not yet recruiting - Clinical trials for Colorectal Cancer Liver Metastasis

Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM

Start date: September 10, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.

NCT ID: NCT06018142 Recruiting - Neoplasm Metastasis Clinical Trials

Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors

Start date: June 1, 2022
Phase:
Study type: Observational [Patient Registry]

It has well accepted that tumor angiogenesis present aberrant vascular architecture and functional abnormalities, which is associated with tumorigenesis, tumor propagation and progression. By locating, separating and tracking microbubbles, the recently introduced and upgraded Ultrasound Localization Microscopy (ULM) surpassed classical wave diffraction limit. However, the acquisition of structural and functional parameters of microcirculation in vivo for ULM is still confined by the compromise between the resolution and penetration depth. The relatively long acquisition time induced the difficulty of motion correction potentially, which hampers the preclinical to clinical application in organs with distinct tissue motion such as the liver. Therefore, we take the lead in studying human liver lesion microvasculature, which remains a challenge for noninvasive, quantitative and functional intravital imaging especially due to its deep-seated location and strong motion. We developed a Super-resolution Ultrasound (SR-US) imaging technique based on ULM to assess its feasibility of visualizing and quantifying microvasculature in human organs.

NCT ID: NCT06013774 Completed - Liver Cancer Clinical Trials

Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure

IXSI
Start date: May 25, 2021
Phase: N/A
Study type: Interventional

To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization