Hepatocellular Carcinoma
Conditions
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.
Interventions
sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China