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Hepatocellular Carcinoma clinical trials

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NCT ID: NCT03708705 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study

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

This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.

NCT ID: NCT03702998 Not yet recruiting - HIV Infections Clinical Trials

Hepatocellular Carcinoma in HIV-infected Individuals in Asian Population

Start date: November 2018
Phase:
Study type: Observational

This is a retrospective study, all HIV-infected individuals followed up at the three designated HIV clinics in Hong Kong with and without HBV and/or HCV co-infection will be included in the analysis. The incidence and mortality of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population will be determined.

NCT ID: NCT03682276 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma

PRIME-HCC
Start date: December 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The PRIME-HCC trial will assess the effects of combination treatment with nivolumab (OPDIVO) and ipilimumab (YERVOY) pre-operatively in hepatocellular carcinoma patients for whom liver resection is planned. The trial will be conducted at a small number of National Health Service hospitals in the UK. Participants will receive two doses of nivolumab and a single dose of ipilimumab in the weeks before their planned surgery.

NCT ID: NCT03668158 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Multi-center Study on Therapy-oriented Molecular Subtyping of Hepatocellular Carcinoma

Start date: October 6, 2018
Phase:
Study type: Observational

The purpose of this study is to establish molecular subtyping of HCC.

NCT ID: NCT03648073 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma

Start date: December 3, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

There is great need for new therapeutic options for patients with hepatocellular carcinoma (HCC). This proposal will assess the feasibility of a novel theranostic approach to HCC using [68Ga]DOTATATE, a recently approved positron emission tomography (PET) ligand for imaging somatostatin receptor (SSTR) positive tumors. In this study, we will use [68Ga]DOTATATE to determine the percentage of HCCs that express adequate levels of SSTR for treatment with targeted radionuclide therapy (TRT) using the therapeutic SSTR ligand [177Lu]DOTATATE. This radionuclide therapy was FDA approved in January 2018 for treating neuroendocrine tumors (NETs) arising from the gastrointestinal tract, but its use in HCC has not yet been explored. In the long term, we envision using [68Ga]DOTATATE-PET to identify HCC patients with adequate SSTR expression for TRT using [177Lu]DOTATATE. Liver transplantation is the only curative therapy for HCC and is an option for a selected subset of HCC patients. For those who are not candidates for transplantation, locoregional therapies with limited efficacy are available such as percutaneous ablation, arterial chemoembolization, and Y-90 microsphere radionuclide therapies. There are few options for patients who progress or are not candidates for these therapies. The first line systemic therapy is sorafenib, a tyrosine kinase inhibitor. Sorafenib is often not well tolerated due to its side effects and there is need for additional systemic treatments. Multiple tissue-based studies demonstrate SSTR positivity in 20-50% of HCCs.[1-3] However, the fraction of HCCs have high enough levels of SSTR for [177Lu]DOTATATE therapy has not yet been assessed. This research plan is a critical prerequisite for determining the feasibility of this theranostic approach to treating HCC. If we obtain positive results, these data will be critical for designing a combined imaging and therapeutic study in HCC using DOTATATE.

NCT ID: NCT03647163 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Combination Therapy With Intravenous VSV-IFNβ-NIS and Pembrolizumab in Refractory NSCLC and HCC

Start date: November 1, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase I safety run-in study designed to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine efficacy of combination therapy in patients with refractory NSCLC or HCC.

NCT ID: NCT03644511 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment

SORAGO-HCC
Start date: September 28, 2018
Phase:
Study type: Observational

Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type). In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.

NCT ID: NCT03642561 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Start date: September 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

NCT ID: NCT03638141 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab

Start date: October 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.

NCT ID: NCT03630640 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Neoadjuvant and Adjuvant Nivolumab in HCC Patients Treated by Electroporation

NIVOLEP
Start date: September 17, 2018
Phase: Phase 2
Study type: Interventional

Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure . In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques. They allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria . In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume that can be ablated, allowing the removal of large tumors> 5 cm . Furthermore, electroporation (EP) is a new PA technique that does not promote thermoablation but induce tumoral cells apoptosis and is particularly interesting for difficult-to-treat lesions located near vascular or biliary trunks . Inadequate tumour control is then de facto greater in these situations, around 20% at one year. The idea of optimizing HCC curative treatments using neoadjuvant or adjuvant biotherapy, particularly in patients with advanced tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients with in Milan HCC, with an expected low rate of recurrence with only few patients treated by PA. In parallel, the development of new molecules for HCC treatment, especially immunotherapy, seems to give promising results in palliative setting . Furthermore, PA procedures and most likely electroporation induce T-cell recruitement that may foster immunomodulation . Neoadjuvant and adjuvant trials using these new molecules must now be cautiously designed based on the rigorous selection of special populations and therapeutic indications. This project proposes a Phase 2 trial testing the safety and efficacy of treatment with Nivolumab in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent.