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Enrolling by Invitation

NCT Number: NCT07052448

The Efficacy of Sequential RT After Triple Therapy for uHCC

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. OS

    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

    overall survival

Secondary outcomes

  1. PFS

    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

    progression-free survival

  2. ORR

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

    objective response rate

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

The Efficacy of Sequential Radiotherapy After the Combination of Transcatheter Arterial Chemoembolization With Lenvatinib and Anti-PD-1 Antibodies for Unresectable Hepatocellular Carcinoma

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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