The Efficacy of Sequential RT After Triple Therapy for uHCC

N/AEnrolling By InvitationNCT07052448

Fujian Provincial Hospital35 enrolled

Overview

Triple therapy of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies has demonstrated excellent efficacy in unresectable hepatocellular carcinoma (uHCC). However, tumor drug resistance is still a major problem and many patients fail to achieve complete necrosis of the lesions after treatment. This study aimed to investigate the efficacy and safety of sequential radiotherapy after triple therapy in patients with uHCC to improve tumor response rate.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodiesDRUG

sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with HCC and assessed as unresectable by multidisciplinary team (MDT) * Patients who achieved PR or SD after triple therapy according to the mRECIST and did not meet the criteria for radical surgical resection or could not tolerate surgical treatment * Patients who received sequential radiotherapy * Age between 18 and 75 years * Child-Pugh class A or B * Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 Exclusion Criteria: * Previous acceptance of other antitumor treatments * Treatment in conjunction with other treatment regimens, such as radiofrequency ablation and chemotherapy * History of other malignancies * Incomplete data.

Locations (1)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

overall survival

Time frame: From date of randomization until the date of date of death from any cause or the most recent follow-up, whichever came first, assessed up to 100 months

Secondary Outcomes

PFS

progression-free survival

Time frame: From date of randomization until the date of first documented progression, the date of death from any cause or the date of most recent follow-up, whichever came first, assessed up to 100 months

ORR

objective response rate

Time frame: From date of randomization until the date of the best tumor response is achieved, assessed up to 100 months

Data from ClinicalTrials.gov

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