The Efficacy of Sequential RT After Triple Therapy for uHCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of Sequential Radiotherapy After the Combination of Transcatheter Arterial Chemoembolization With Lenvatinib and Anti-PD-1 Antibodies for Unresectable Hepatocellular Carcinoma
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.
Interventions
- Drug sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies
sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies
Primary outcome measures
- 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]
Secondary outcome measures (2)
- 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]
- ORR [Time frame: From date of randomization until the date of the best tumor response is achieved, assessed up to 100 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuzhou University Affiliated Provincial Hospital — Fuzhou
Identifiers
NCT: NCT07052448 · TALENP006