The Efficacy of Sequential RT After Triple Therapy for uHCC

NCT07052448 | Enrolling By Invitation DMC

• 1 other identifier: TALENP006
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

  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 (2)

• 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

• ORR

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

Study Arms (1)

sequential radiotherapy after triple therapy

Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies

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

Interventions

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

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

sequential radiotherapy after triple therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 4, 2025
• Study Start: November 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)