Sequential TACE-SBRT Combined With Targeted Immunotherapy for Patients With Intermediate to Advanced Liver Cancer

N/AActive Not RecruitingNCT07230080

Nanfang Hospital, Southern Medical University17 enrolled

Overview

The goal of this clinical trial is to evaluate whether sequential transarterial chemoembolization (TACE) followed by stereotactic body radiotherapy (SBRT) combined with targeted immunotherapy is effective and safe for patients with intermediate to advanced hepatocellular carcinoma (HCC) who are not eligible for curative treatment such as surgery or liver transplantation. This is a single-center, single-arm, retrospective study. All participants included in the analysis will have received the combined treatment regimen. The main question the study aims to answer is: Can sequential TACE-SBRT combined with targeted immunotherapy improve the objective response rate (ORR) in patients with intermediate to advanced HCC? Interventions Participants in this study have undergone the following treatments: TACE: a minimally invasive procedure to block the blood supply to the tumor while delivering chemotherapy directly. SBRT: a highly precise form of radiation therapy targeting the liver tumor. Targeted immunotherapy: systemic treatment that stimulates the immune system to recognize and attack cancer cells. Participant Population The study includes adult patients diagnosed with intermediate to advanced HCC who were not candidates for curative resection or transplantation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HCC - Hepatocellular Carcinoma SBRT TACE Immunotherapy Targeted Therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Unresectable hepatocellular carcinoma (HCC) * CNLC stage IIb-IIIb * Target lesion(s) not previously treated with local therapy * Child-Pugh class A5-B7 liver function * Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 * At least one measurable lesion based on modified RECIST (mRECIST) criteria Exclusion Criteria: * Diagnosis of any malignant disease other than primary liver cancer within 3 years prior to enrollment * Currently participating in another interventional clinical study * History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation * Presence of any severe or uncontrolled systemic disease * Any medical history, comorbid condition, treatment, or abnormal laboratory finding that may interfere with study results or hinder full participation, or any other situation that the investigator considers inappropriate for enrollment * Investigator's judgment of other potential risks making the patient unsuitable for participation in this study

Outcomes

Primary Outcomes

Objective Response Rate (ORR) according to mRECIST

Objective response rate (complete response + partial response) assessed by mRECIST based on imaging evaluation.

Time frame: At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months)

Secondary Outcomes

Overall Survival (OS)

Time frame: From treatment initiation until death from any cause, up to study completion (an average of 26 months)

Progression-Free Survival (PFS) according to mRECIST

Time from treatment initiation to disease progression or death, assessed by mRECIST.

Time frame: From treatment initiation until disease progression or death, whichever occurs first, up to study completion (an average of 15 months)

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

Time frame: From treatment initiation through study completion, up to 18 months