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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT04667351 Recruiting - Clinical trials for HepatoCellular Carcinoma

HAIC of Oxaliplatin, and 2400 mg/m² 5-fu vs HAIC of Oxaliplatin, and 1200 mg/m² 5-fu for Unresectable HCC: a Randomised Phase 3 Non-inferiority Trial

Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.

NCT ID: NCT04665609 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC

Start date: March 5, 2021
Phase: Phase 3
Study type: Interventional

In this study, investigators aimed to evaluated the efficacy and safety of microwave ablation combined with anlotinib and TQB2450 Solution in patients with advanced hepatocellular carcinoma. Patients were randomly assigned at a one-to-one ratio to receive microwave ablation plus anlotinib and TQB2450 Solution or microwave ablation plus TQB2450 Solution. Primary end points were objective response rate(ORR). Second end points include overall survival, progression-free survival and disease control rate. Safety was assessed in all patients.

NCT ID: NCT04665362 Not yet recruiting - Clinical trials for Advanced/Metastatic Hepatocellular Carcinoma

IIT Study of M1-c6v1 Combined With SHR-1210 and Apatinib in Patients With HCC

Start date: January 25, 2021
Phase: Phase 1
Study type: Interventional

This is a single arm and open-label phase I trial to evaluate the safety, tolerability and efficacy of the oncolytic virus M1 (M1-c6v1)(iv 1×109 CCIC50, 1 dose per day, on day 1-5 each 28 day cycle) combined with anti-PD-1 antibody SHR-1201 (iv, 200 mg, once every two weeks) and Apatinib (po. 250 mg qd ) in the patients with advanced/metastatic hepatocellular carcinoma. 10 participants will be sequentially enrolled. The treatment duration is 12 months. All patients continue combination treatment until disease progression, unacceptable toxicity, death, or discontinuation for any reason.

NCT ID: NCT04663035 Recruiting - Clinical trials for Recurrent Hepatocellular Carcinoma

Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC

Start date: December 21, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.

NCT ID: NCT04660929 Active, not recruiting - Breast Cancer Clinical Trials

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Start date: February 2, 2021
Phase: Phase 1
Study type: Interventional

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

NCT ID: NCT04659005 Completed - Clinical trials for Hepatocellular Carcinoma

Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is a common malignancy with poor prognosis worldwide. The asymptomatic of early-stage HCC may lead most patients diagnosed at advanced stages. This highlights the importance of HCC screening among high-risk populations to detect HCC at early stages and achieve better survival. Hepatitis B virus (HBV) infection is a major cause of HCC in China, but the utilization of HCC screening is suboptimal among patients with HBV infection. Currently, there are no-theory based intervention, to our knowledge, has been reported to improve HCC screening decision-making and uptake among patients with HBV infection . Therefore, based on our previous systematic review, the current study has proposed a nurse-led decision counseling program to improve decision-making and uptake of HCC screening among patients with HBV infection in mainland China. Participants in intervention group will receive nurse-led decision counseling. The intervention components include 40-minute education and tailored information regarding HCC screening. At the second week, decision support will be provided through 30-minute telephone call. At the third week, another telephone call (20 minutes) will be provided to help participants identify and address barriers to HCC screening. Participants in control group will receive usual care. After the intervention and at 3-month follow-up, the study will collect data related to HCC screening uptake rates. Findings are paramount to promote informed choice in HCC screening and early HCC detection to improve survival outcomes among patients with HBV infection.

NCT ID: NCT04658147 Recruiting - Clinical trials for Hepatocellular Carcinoma

Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)

Start date: May 28, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.

NCT ID: NCT04653818 Completed - Clinical trials for Hepatocellular Carcinoma

HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial

RCT
Start date: October 5, 2020
Phase: Phase 4
Study type: Interventional

Data regarding hepatocellular carcinoma (HCC) recurrence after directly acting antivirals (DAAs) given for hepatitis C virus treatment are contradictory. Surprisingly, some studies reported that DAAs are accompanied with higher HCC recurrence. But, other studies showed no rise or even decrease in HCC recurrence. Most of these studies were retrospective and some were non-randomized prospective studies. Here investigators aim to perform a randomized controlled trial to study this issue.

NCT ID: NCT04653701 Recruiting - Clinical trials for Hepatocellular Carcinoma

Safety and Efficacy of DEB-TACE Performed With a Novel Reflux-control Microcatheter in Patients With HCC

Start date: November 14, 2020
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: Hepatocellular carcinoma is the fifth most frequent cancer in the world, with a diagnosis of more than 500,000 new cases per year. It is considered the third leading cause of cancer mortality and presents well-defined risk factors. Liver cirrhosis is the main risk factor for developing HCC, therefore screening programs in cirrhotic patients will allow the early diagnosis of this neoplasia. Despite this, most HCCs are diagnosed at a stage in which the application of curative therapies is no longer possible. Hepatic transarterial chemoembolization (TACE) belongs to the arterially directed embolization therapies for the treatment of unresectable early-to-advanced hepatocellular carcinoma (HCC). It is the only therapy that has shown to improve survival in intermediate-stage HCC. Drug-eluting beads (DEB)-TACE has shown to provide slow drug elution, reduced liver and systemic toxicity, increased local drug concentration, and tissue necrosis. Aside from TACE, other transarterial options include bland embolization, or hepatic artery embolization (HAE), and transarterial radioembolization (TARE). All have an acceptable safety profile, and each has its associated procedural and peri-procedural complications. One potential complication that may occur during all embolization procedures is when the embolic material migrates outside of the desired treatment area, leading to non-target embolization (NTE). In fact, when collateral vessels are embolized, there is a risk that these may be feeders of non-target tissue or organs. NTE following TACE in particular may lead to a double-layer problem: dangerous components affecting healthy tissue, one ischemic and one related to cytotoxicity from the chemotherapeutic agent, which may have clinical consequences, and potential incomplete treatment of the lesion (due to beads being "deviated" from target). NTE is highly recognized, but often thought to be uncommon, and although different complications can be caused by it, there may appear to be no evidence of NTE during the intraprocedural imaging. To avoid the complications due to NTE, apart from the importance of the pre-, intra- and post-procedural imaging, and the thorough study of the anatomical picture, the catheters/microcatheters should also be chosen with reason and care. In particular, selective catheterization should be achieved by placing the microcatheter tip as close as possible to the target, through the specific branch/branches supplying it. However, even with the microcatheter selectively positioned in the vessel to be embolized, the risk of NTE might not be eliminated, since it could happen as a result of changes in flow dynamics that occur during embolization, particularly when the endpoint is stasis. These changes could result in reflux into non-target territories and, as such, might be better prevented with the use of microcatheters intended to reduce reflux. To this purpose, the use of a dedicated delivery device should be taken into consideration, in order to optimize and save time during the procedure. Microcatheters are commonly used during most arterial embolization procedures, and as explained above, there is a strong rationale to use a reflux-control microcatheter - like Sequre - for DEB-TACE. The main expectation is to achieve technical success with Sequre in all patients with a reachable target lesion, with the intent not only to minimize potential damage to surrounding tissue, but also to potentially deliver more treatment embolics, as all the beads are (re)directed towards the target. The use of small diameter particles (100 micron-TANDEM ® spheres), induces superior tumor necrosis response (Urbano et al., European Journal of Radiology, 2020); with the synergistic effect of being administered through the SEQURE anti-reflux protection system, there is reason to believe that it will be possible to administer maximum doses of doxorubicin, while avoiding the occlusion of non-target arterial segments (SYNERGIC EFFECT). STUDY PROPOSAL: We propose a prospective observational study with data collection from a single center (Virgen de las Nieves University Hospital-Granada), for a period that ranges October 2020-December 2021. Here summarized the inclusion criteria and contraindications: Inclusion criteria - BCLC B and or some case BCLC A - Both genders - Over 18 years. - Bilirubin less than 3 gr/dl. - No contraindications to the use of iodinated contrast - Absence of chronic kidney disease - ECOG 0-1. - Absence of encephalopathy. - Informed consent. Contraindications - Advanced liver disease. - Thrombosis or reversal of portal flow. - Vascular invasion. - Extrahepatic spread. - Contraindication to administration of cytostatics. - Contraindication to angiographic procedure.

NCT ID: NCT04653389 Terminated - Clinical trials for Hepatocellular Carcinoma

Perioperative Therapy for Hepatocellular Carcinoma

Start date: December 26, 2020
Phase: Phase 2
Study type: Interventional

This study aims to observe and evaluate the efficacy and safety of the perioperative multidisciplinary therapy that combines the preoperative transarterial chemoembolization(TACE) and the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection with or without radiotherapy of vein tumor thrombus followed by postoperative anti-PD-1 injection in the treatment of technically resectable hepatocellular carcinoma patients with vein thrombosis.