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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT04204577 Recruiting - Clinical trials for BCLC Stage C Hepatocellular Carcinoma

The Safety and Efficacy of Thermal Ablation Combined With Apatinib and Carilimub for Advanced Liver Cancer

Start date: November 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for the treatment of advanced liver cancer.

NCT ID: NCT04202523 Recruiting - Clinical trials for Hepatocellular Carcinoma

Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma

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

Liver cancer is a clinically high-grade malignant tumor, and the current incidence rate is increasing year by year. It has become the third most malignant tumor after gastric cancer and lung cancer, and has a high mortality rate. The patient's five-year survival rate is less than 8.5%, which the second leading cause of cancer death is a serious threat to the health of patients. Surgical resection is the preferred treatment plan for liver cancer. With the development of medical technology, the clinical efficacy of liver cancer has been significantly improved, but postoperative recurrence has not been effectively controlled. According to statistics, the recurrence rate of liver cancer after 5 years is as high as 77.0%. Even for small liver cancer resection, the recurrence rate is 40.0%~50.0% within 5 years after operation. At the same time, for recurrent liver cancer, surgical resection is still the preferred treatment plan, but affected by the location, size, distal metastasis and multi-center pathogenesis of liver cancer, only 10.4%~31.0% can be surgically removed. In recent years, RFA has been widely used in liver cancer and recurrent liver cancer due to its unique advantages such as minimally invasive, simple operation, wide indication, reproducible, low cost, and accepted by patients, and has achieved satisfactory results. However, study found that because of the special location of recurrent liver cancer, its multi-center origin, and the characteristics of intrahepatic micrometastasis, it is often accompanied by microvascular tumor thrombus (MVI), which greatly increases the risk of liver cancer recurrence. Moreover, since the treatment of RFA can only be effective for the local detection of recurrent foci, and the effect of detecting small lesions is poor, there is a higher risk of recurrence. The use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm and microvascular invasion is not safe and is often associated with higher rates of recurrence and shorter patient survival. On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin. Whether combined radiotherapy and RFA treatment of liver cancer and recurrent liver cancer can further improve the clinical efficacy, there are few reports. Therefore, the short-term and long-term effects of radiotherapy combined with RFA in the treatment of liver cancer and recurrent liver cancer are studied to provide guidance for clinical treatment.

NCT ID: NCT04191889 Recruiting - Clinical trials for C-staged Hepatocellular Carcinoma in BCLC Classification

A Trial of Hepatic Arterial Infusion Combined With Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC Classification

TRIPLET
Start date: April 13, 2020
Phase: Phase 2
Study type: Interventional

This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab (Triplet-combined Therapy) for C-staged Hepatocellular Carcinoma in BCLC classification. The primary outcome measure is to evaluate the objective response rate (ORR) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification. The secondary Outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) [ Time Frame: 6- and 12-month], overall survival rate (OSR) [ Time Frame: 6- and 12-month], the median progression-free survival time (mPFS) and median overall survival time (mOS) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification. Moreover, this study aims to assess the safety and tolerability of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification.

NCT ID: NCT04183088 Recruiting - Clinical trials for Advanced Hepatocellular Carcinoma

Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular Carcinoma

Start date: December 16, 2020
Phase: Phase 2
Study type: Interventional

Combination of anti-angiogenic molecular targeted therapy and anti- programmed cell death -1 immune checkpoint inhibitor (ICI) therapy has shown promising antitumor activity in multiple cancer types, including patients with advanced hepatocellular carcinoma (HCC). The safety profile and optimal dosage of targeted therapy should be carefully evaluated by clinical trials. Regorafenib is one of the standard second-line systemic therapy for advanced HCC. The present study will test the safety and efficacy of combination of regorafenib and tislelizumab, an anti-programmed cell death-1 ICI. The investigator(s) thus hypothesized that combination of tislelizumab and regorafenib is a tolerable regimen and may improve treatment efficacy for patients with advanced HCC. The present study will explore safety and efficacy of the combination of tislelizumab plus regorafenib as first-line therapy for advanced HCC.

NCT ID: NCT04181931 Recruiting - Clinical trials for Hepatocellular Carcinoma

Neo-TACE-HAIC for PVTT-HCC

NeoconceptC
Start date: December 16, 2019
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE). Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

NCT ID: NCT04180072 Recruiting - Clinical trials for Carcinoma, Hepatocellular

Atezolizumab Plus Bevacizumab With HCC and HBV Infection

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

This is a single-arm clinical trial. The main objective is to determine the efficacy of atezolizumab+bevacizumab therapy in patients with advanced hepatocellular carcinoma and with chronic hepatitis B virus infection. All eligible patients will receive atezolizumab + bevacizumab therapy.

NCT ID: NCT04170179 Recruiting - Clinical trials for Hepatocellular Carcinoma

Systemic Chemotherapy Plus Lenvatinib and Toripalimab for HCC With Extrahepatic Metastasis

Start date: November 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with hepatocellular carcinoma with extrahepatic metastasis

NCT ID: NCT04169399 Recruiting - Clinical trials for Hepatocellular Carcinoma

Toripalimab Plus Stereotactic Body Radiotherapy for HCC With PVTT

Start date: November 17, 2019
Phase: Phase 2
Study type: Interventional

To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.

NCT ID: NCT04167293 Recruiting - Clinical trials for Hepatocellular Carcinoma

Combination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01)

ISBRT01
Start date: November 16, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Although sorafenib is the standard treatment for hepatocellular carcinoma with portal vein invasion, the outcome of these patients remains very poor, with a median survival time of 5.5 to 7.2 months. It has been demonstrated that first-line treatment with transarterial chemoembolization plus radiotherapy could provide more favorable survival than sorafenib alone. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after treatment in these patients; therefore, searching for new strategies to improve efficacy is necessary. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced HCC. Combining radiotherapy with immune checkpoints showed promising response rates and improved survival in several solid tumor types. The aim of this randomized study was to investigate the efficacy and safety of stereotactic body radiotherapy followed by sintilimab (an anti-PD-1 antibody) compared with stereotactic body radiotherapy alone for hepatocellular carcinoma with portal vein invasion after arterially directed therapy.

NCT ID: NCT04163627 Recruiting - Clinical trials for Hepatocellular Carcinoma

Changing Trends in HCC Procedures

Start date: November 30, 2019
Phase:
Study type: Observational

In France, as in most countries, the incidence of primary liver cancer has increased significantly since the 1980s. In the United States, a study estimating cancer incidence and mortality rates in the coming years predicts that primary liver cancer will become the 3rd leading cause of cancer death from 2030 onwards, behind lung and pancreatic cancer, but ahead of colorectal cancer. This increase in incidence could be explained on the one hand by an increase in the incidence of chronic liver diseases, particularly those related to alcohol and metabolic steatopathies in the West, and on the other hand by improved management of the consequences of cirrhotic disease, which in turn increases the time needed for hepatocellular carcinoma (HCC) to form and develop. The management of a patient with hepatocellular carcinoma is complex because of the underlying cirrhotic disease, which hinders the development of many therapies. Thus, the patient's prognosis depends as much on the tumour extension as on the severity of the underlying chronic liver disease, and the choice of appropriate treatment is based on optimizing the balance between maximum antitumor efficacy and limited liver toxicity. It is in this context that minimally invasive technical acts, whether local or local-regional, have developed significantly in recent years. Percutaneous tumor destruction techniques have become highly diversified with the development of microwave ablatherm, multipolar radiofrequency, or irreversible electroporation. For intra-arterial treatments, hepatic arterial chemoembolization remains the reference treatment for BCLC B stages. Alongside it, Yttrium 90 radio-embolization is booming, although its precise place remains to be defined in the therapeutic arsenal. Surgical techniques have also progressed, with the development of laparoscopic resections and improved liver transplant management. Finally, external radiotherapy is a recourse solution that can make it possible to propose a therapeutic solution in selected patients. This multidisciplinary management of the HCC is in constant evolution and improvement, which justifies regularly carrying out an inventory of the frequency of these various technical acts at the national level. The objective of our study is to analyze the evolution, over the last 10 years and at a national level, of the various technical procedures available in the HCC therapeutic arsenal based on data from the french national PMSI database.