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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT04451603 Completed - Clinical trials for Hepatocellular Carcinoma

LiverMultiScan Analysis of MRI Scans in HCC

Start date: October 19, 2018
Phase:
Study type: Observational

This project is a pilot study to interrogate the potential of LMS as a predictive tool for the selection of therapy for HCC patients. The reliability of LMS to predict patients' response following HCC therapy will leverage on an algorithm that is built from the pool of MRI scans from HCC patients pre- and post-treatment. In the study, MRI scans of 30 HCC and metastatic colorectal cancer (CM) patients (ratio of 4:1) will be analysed. CM cancer patients include patients whose cancers metastasized from colorectal cancer or primary liver cancer. These patients will either receive one of the treatment, surgical resection, Y90 or systemic therapy. A total of 4 MRI scans will be taken for each patient; the first MRI scan will be taken within a month before treatment initiation and the remaining MRI scans will be taken at the 1st, 3rd and 9th month post-initiation of treatment.

NCT ID: NCT04444167 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

Start date: July 7, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

NCT ID: NCT04443322 Recruiting - Clinical trials for Liver Transplant; Complications

Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )

Dulect2020-1
Start date: September 19, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC.The primary hypothesis of this study are that patients with locally advanced HCC could benefit from durvalumab plus lenvatinib before liver transplant; patients with metastatic unresectable HCC could also benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; or recurrence-free survival (RFS) if patients with locally advanced HCC underwent liver transplant; 2) Objective Response Rate (ORR); and 3) Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

NCT ID: NCT04443309 Recruiting - Clinical trials for Hepatocellular Carcinoma

Lenvatinib in Combination With Camrelizumab as First-Line Therapy in Patients With Advanced HCC

Start date: September 11, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single arm, open-label, non-randomized and single-center phase I/II clinical study, to evaluate the the safety, tolerance and efficacy of Lenvatinib plus Camrelizumab as first-line therapy in patients with advanced Hepatocellular Carcinoma.

NCT ID: NCT04443049 Recruiting - Clinical trials for Hepatocellular Carcinoma

To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.

Start date: July 10, 2020
Phase: N/A
Study type: Interventional

Currently the available first line palliative therapy for advanced HCC is Sorafenib and Lenvatinib of which Lenvatinib is tolerated better. Unfortunately, patients tend to progress after few months of therapy. Therefore it is imperative, to do trials by combinative therapy to the available therapy for added survival benefits and quality of life with advanced HCC. In this regard, Mebendazole appears to be a good choice for drug repurposing as it has shown very promising results either alone or in combination with other therapies in tumors of GI origin and CNS tumors. With regard to HCC Mebendazole has been found to be effective in vitro system of HCC and preclinical models. However no clinical trials have been initiated till now. The key hallmark features of HCC include activation of MAPK and angiogenesis which in turn are targeted by RTK inhibitors such as Sorafenib and Lenvatinib. In this regard Mebendazole has broad range of action by not only inhibiting angiogenesis and pro-survival pathways of MAPK, but by also inhibiting the secretion of MMPs and Tubulin polymerization which can all be beneficial in tumor regression and prevention of chemo-resistance in HCC. Mounting of a strong immune response plays an important role in identification of tumor antigen and thereby clearing of tumors. While Mebendazole can modulate the tumor, the data is scant with respect to the role of the drug. Hence repurposing Mebendazole as a combinatorial therapy appears a promising approach and forms the basis of the present work. We hypothesize that combinatorial therapy of addition of mebendazole to lenvatinib will prove more beneficial than lenvatinib alone in increasing the overall survival of patients with advanced HCC. To prove the mechanistic effects of mebendazole on HCC, we will also conduct a animal study in preclinical mice model of HCC with the help of our animal house facility. The animal study will help us to understand the additional benefits from mebendazole and lenvatinib with objective evidence of liver biopsy which is not feasible in humans.

NCT ID: NCT04442581 Terminated - Clinical trials for Advanced Hepatocellular Carcinoma

Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer

Start date: April 20, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well cabozantinib and pembrolizumab work for the first-line treatment of patients with liver cancer who are not eligible for local therapy (i.e. advanced stage). Cabozantinib may stop the growth of tumor cells by blocking some cell surface receptors and signaling pathways inside the tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer. Giving cabozantinib and pembrolizumab together may work better in treating patients with advanced liver cancer compared to cabozantinib or pembrolizumab alone.

NCT ID: NCT04435977 Recruiting - Hepatocarcinoma Clinical Trials

Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

Immunocabo
Start date: January 30, 2020
Phase: Phase 2
Study type: Interventional

This is an open-label, single-center, Phase II trial designed to estimate in terms of PFS the efficacy of cabozantinib, given as second- or third- line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 antibodies.

NCT ID: NCT04434989 Recruiting - Clinical trials for Hepatocellular Carcinoma

SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

SAIL
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared with RFA.

NCT ID: NCT04430452 Recruiting - Clinical trials for Advanced Hepatocellular Carcinoma

Hypofractionated Radiotherapy Followed by Durvalumab With or Without Tremelimumab for Liver Cancer After Progression on PD-1 Inhibition

Start date: February 4, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing) after treatment with PD-1 inhibitor immunotherapy. In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.

NCT ID: NCT04428437 Terminated - Clinical trials for Hepatocellular Carcinoma

Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors

Start date: July 2, 2022
Phase:
Study type: Observational

The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors. Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib. CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1. The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.