The Efficacy of Sequential RT After Triple Therapy for uHCC

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies

• Registration Number: NCT07052448
• Lead Sponsor: Fujian Provincial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-21
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sequential radiotherapy after triple therapy	sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies	Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies

Primary Outcome Measures

Name	Time	Method
OS	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	overall survival

Secondary Outcome Measures

Name	Time	Method
PFS	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	progression-free survival
ORR	From date of randomization until the date of the best tumor response is achieved, assessed up to 100 months	objective response rate

Trial Locations

Locations (1)

Fuzhou University Affiliated Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China