Clinical Study of the Efficacy & Safety of Transhepatic Arterial

Status Active, not recruiting

Clinical Trial Summary

ICIs combined with AATDs have gradually become the mainstream treatment modality for advanced hepatocellular carcinoma, and more related clinical trials are underway. This is undoubtedly a breakthrough and the main direction for improving the overall 5-year survival rate of the liver cancer population in the next decade, and a touchstone for exploring the development and value of liver surgery in the era of comprehensive treatment for advanced hepatocellular carcinoma. Overall, there are relatively few reports on various types of translational therapy for advanced HCC, probably for the following two reasons: (1) advanced hepatocellular carcinoma is complex, rapidly progressing, difficult to treat, and has low translational efficiency; (2) the existing translational therapy strategies are highly selective in terms of applicable population, complex treatment process, and institutional dependence, and cannot achieve efficient and successful translation. At present, there are few studies reported on the application of TACE+ICIs+AATDs to carry out translational therapy. In the absence of relevant guidelines for reference, advanced hepatocellular carcinoma may be the best entrance to carry out translational therapy with ICIs combined with AATDs, and after satisfactory results are achieved in the treatment of this group of patients, a point-to-point effect can be generated, facilitating the transformation of TACE+ICIs+AATDs The target population of TACE+ICIs+AATDs translational therapy can be further expanded. To promote the development of hepatocellular carcinoma treatment and improve the long-term survival rate of the overall hepatocellular carcinoma population. In this study, we enrolled patients with advanced HCC and used TACE+ICIs+AATDs for conversion therapy to improve the conversion rate, so that unresectable HCC patients could be converted to a chronic disease state and achieve long-term survival on the one hand, and provide potential for sequential surgical treatment on the other. The drug of choice is lenvatinib. This study provides a basis for the clinical application of translational therapy for advanced hepatocellular carcinoma.

Clinical Trial Description

n/a

Study Design

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Clinical Trial Details

NCT number	NCT05131698
Study type	Interventional
Source	Cancer Hospital of Guangxi Medical University
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	March 1, 2021
Completion date	July 5, 2024

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See also
Status	Clinical Trial	Phase
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Recruiting	`NCT06070636` - bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma	N/A
Not yet recruiting	`NCT05286320` - Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.	Phase 1/Phase 2
Recruiting	`NCT05920863` - Lenvatinib Combined With Tislelizumab and TACE Applied as Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma With High-risk Recurrence Factors	Phase 2
Recruiting	`NCT04911959` - Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC	Phase 1/Phase 2
Recruiting	`NCT05444478` - Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma	N/A
Recruiting	`NCT04669496` - Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors	Phase 2/Phase 3
Recruiting	`NCT06333561` - HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
Recruiting	`NCT04955743` - Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma	Phase 2
Active, not recruiting	`NCT05156788` - Tislelizumab（Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer	Phase 2
Completed	`NCT06435013` - Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC
Active, not recruiting	`NCT04791176` - Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Study of the Efficacy and Safety of Transhepatic Arterial Chemoembolization Combined With Tislelizumab and Lenvatinib in Patients With Advanced Unresectable Hepatocellular Carcinoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms