Study on the Efficacy and Safety of Transarterial Chemoembolization Combined with Targeted Immunotherapy in Patients with Unresectable Hepatocellular Carcinoma

November 28, 2024 updated by: Yao Xie
This study is a single-center, single-arm, prospective study. It enrolls patients with unresectable hepatocellular carcinoma (HCC). The study aims to investigate the efficacy and safety of transarterial chemoembolization combined with targeted immunotherapy in patients with unresectable HCC, providing treatment guidance for these patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Primary liver cancer (PLC) represents the sixth most common cancer and the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) accounts for 75% to 85% of PLC cases, with the main etiologies being hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Approximately 44-62% of HCC patients develop portal vein tumor thrombus (PVTT), which plays a major role in disease prognosis. These patients have a poor prognosis, with a median survival time of 2.7-4 months without any intervention, posing a significant challenge to clinicians. Both the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines recommend that HCC patients with PVTT be classified as Barcelona Clinic Liver Cancer stage C (BCLC-C) and receive systemic therapy.For unresectable HCC, trans-arterial chemoembolization (TACE) is one of the most commonly used techniques and can significantly improve survival rates. Compared to best supportive care, TACE can significantly extend the overall survival (OS) of PVTT type I-III HCC by nearly 3 months . Sorafenib, a tyrosine kinase inhibitor (TKI), is the first approved targeted drug and has shown some survival benefits in advanced HCC compared to placebo. The REFLECT trial demonstrated that lenvatinib improved time to progression (TTP) and objective response rate (ORR) compared to sorafenib [13]. Two other studies also confirmed that TACE combined with lenvatinib had significantly better clinical efficacy in HCC with PVTT compared to TACE combined with sorafenib.Increasing evidence suggests that immune checkpoint inhibitors (ICIs) combined with multi-kinase TKIs or vascular endothelial growth factor (VEGF) antibodies are becoming a trend in the treatment of advanced HCC. Moreover, the inflammatory factors produced and released during TACE treatment have a priming effect on adaptive immunity; TACE can induce spontaneous T-cell responses and modulate the tumor microenvironment. The combined use of TACE and ICIs may more effectively promote antitumor immune reconstitution. A retrospective study reported that TACE combined with camrelizumab and apatinib significantly improved OS in HCC, with an ORR superior to the dual regimen of apatinib and camrelizumab. Another retrospective study involving 22 patients with advanced HCC showed that using lenvatinib and camrelizumab with TACE could control tumor progression and extend survival. However, data on this triple regimen for treating unresectable hepatocellular carcinoma are limited. Therefore, this study will provide evidence for the triple regimen in treating unresectable hepatocellular carcinoma.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Unresectable Liver Cancer

Description

Inclusion Criteria:Voluntarily join this study and sign the informed consent form;Age ≥18 years and ≤68 years, receiving arterial chemoembolization combined with targeted immunotherapy, regardless of gender;At least one measurable lesion as defined by the Modified Response Evaluation Criteria in Solid Tumors (mRECIST);Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1;Child-Pugh score ≤7;Generally good condition, such as albumin >25 g/L, white blood cells >3×10^9/L (excluding causes such as hypersplenism), platelets >50×10^9/L, etc.;Expected survival >12 weeks;No fertility requirements.

Exclusion Criteria:Uncontrolled hypertension;Active autoimmune diseases;Concurrent other untreated malignancies;Pregnant or breastfeeding women;Active bleeding tendency or coagulation disorders;Severe liver, kidney, heart, or bone marrow dysfunction;Severe allergy to iodine contrast agents;Other contraindications to the use of TACE, lenvatinib, camrelizumab, atezolizumab, bevacizumab, etc.;The investigator believes that accompanying medical history may affect the subject's safe completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Evaluation
Time Frame: tree years
The time from the date of the first dose of lenvatinib to disease progression or death from any cause.
tree years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yao Xie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTXY30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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