View clinical trials related to Hepatocellular Carcinoma.
Filter by:This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma
This multicenter retrospective study which included patients with hepatocellular carcinoma (HCC) who received conversion or neoadjuvant therapy to explore the best treatment options and the best benefit group.
Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. According to GLOBOCAN 2018 data, liver cancer is the sixth most prevalent tumor in the world, with about 841,100 new liver cancer cases and 781,600 deaths per year globally, which is the second leading cause of tumor deaths in men worldwide. China is a high incidence area of liver cancer, accounting for about 50% of the global incidence and deaths. The treatment of HCC varies according to disease stage, which is based on the BCLC classification system, Child-Pugh liver function rating, and extent of disease. Approximately 30% of HCC cases are diagnosed in the early stages (i.e., BCLC stage 0 or A), and the main treatment options include surgical resection, ablation techniques, and liver transplantation. However, the 5-year recurrence rate remains as high as 70%. The recommended treatment for intermediate stage HCC (i.e., BCLC stage B) is hepatic artery intervention, i.e., transarterial chemoembolization (TACE), but the scope of applicability is limited due to concomitant disease and liver impairment factors, some patients do not derive a survival benefit from it, and patients ultimately progress after treatment and are no longer suitable for further TACE. In recent years, the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted, and studies have reported the feasibility of target drugs combined with ICI, TACE or HAIC for the treatment of unresectable hepatocellular carcinoma. The therapeutic aim of Adebrelimab (SHR-1316) is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells, so that T cells can re-recognize tumor cells and produce killing effects on them. This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy (FOLFIRI) in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma.
1. Study population [TB511 Monotherapy Cohort for Phase I and Phase IIa Clinical Trial] Participants with an advanced solid tumor who are either refractory or intolerant to standard of care (SoC). [Immune checkpoint inhibitors (ICIs) Combination Therapy Cohort for Phase IIa Clinical Trial] Participants with advanced solid tumor who have either not responded to or have relapsed after ICIs that are anti-PD-1 or PD-L1 inhibitors and who have no standard of care available. 2. Objectives of the Clinical Trial [Phase I Clinical Trial] 1) Primary Objective - To evaluate the safety and tolerability of TB511 monotherapy in Participants with advanced solid tumor to determine maximum tolerated dose (MTD) and recommended Phase IIa dose (RP2D). 2) Secondary Objectives - To evaluate the safety of TB511 monotherapy. - To evaluate the objective response rate (ORR) and anti-tumor effect (based on Response Evaluation Criteria in Solid Tumors Version 1.1, RECIST v1.1) of TB511 monotherapy. - To evaluate the pharmacokinetic characteristics of TB511 monotherapy. 3) Exploratory Objectives - To compare the changes in biomarker levels of TB511 monotherapy. - To evaluate immunogenicity by measuring anti-drug antibodies against TB511 [Phase IIa Clinical Trial] 1) Primary Objective - To evaluate the ORR of TB511 monotherapy and combination therapy with Pembrolizumab in Participants with advanced solid tumors (based on RECIST v1.1). 2) Secondary Objectives - To evaluate the disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) of TB511 monotherapy and combination therapy with Pembrolizumab. - To evaluate the safety and tolerability of TB511 monotherapy and combination therapy with Pembrolizumab. - To evaluate the pharmacokinetic characteristics of TB511 monotherapy and combination therapy with Pembrolizumab. 3) Exploratory Objectives - To compare the changes in biomarker levels of TB511 monotherapy. - To evaluate immunogenicity by measuring anti-drug antibodies against TB511
This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume < 700ml or estimated liver-GTV V5 < 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection.
Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC.
Radiation therapy is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma. Our previous preclinical investigation revealed that radiotherapy can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving hepatocellular carcinoma patients. Given that radiotherapy represents a standard therapeutic approach for unresectable hepatocellular carcinoma, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive radiotherapy for hepatocellular carcinoma.
This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma. All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma