3120 - Radiotherapy Delays Second-Line Drug Therapy for Oligo Progressive Hepatocellular Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Trial

X. Zhang, K. Zhu, X. Dou, L. Xu, F. Shi, and J. Yue; Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China

Purpose/Objective(s): Hepatocellular carcinoma (HCC) poses a significant challenge due to its aggressive nature and limited treatment options, especially in advanced stages following first-line systemic therapy. This trial is to investigate the efficacy and feasibility of utilizing radiotherapy as a therapeutic intervention to delay the initiation of second-line drug therapy in patients diagnosed with oligo-progressive hepatocellular carcinoma after first-line drug therapy. Materials/

Methods: This multicenter, single-arm, phase II clinical trial (NCT06261047) aims to enroll 36 patients diagnosed with oligo-progressive primary liver cancer subsequent to first-line systemic therapy. Eligibility criteria include patients who have previously received first-line targeted therapy or immuno-targeted therapy for a duration exceeding 3 months and have recently experienced disease oligoprogression. Eligible participants will undergo a comprehensive clinical evaluation, including imaging studies such as CT and MRI, to confirm disease oligoprogression confined to three or fewer involved organs and five or fewer sites of oligometastatic/oligoprogressive lesions. Patients with satisfactory performance status and organ function will receive radiotherapy according to institutional protocols. Radiation oncologists would create customized radiotherapy plans, considering the location, size, and number of oligometastatic/oligoprogressive lesions for each patient. Radiotherapy would be delivered at 60 Gy BED (Biologically Effective Dose) or higher to oligoprogressive lesions. The current systemic treatment regimen is continued until disease progression occurs, rather than switching to second-line systemic treatment. The primary endpoint of the trial is progression-free survival (PFS). The secondary endpoints include the objective remission rate (ORR), overall survival (OS), disease control rate (DCR), and duration of disease remission (DOR).
Results: So far, we have enrolled 11 patients in the trial.
Conclusion: To be determined.

Abstract 3120 – Table 1

Study Phase	Phase II
Primary Endpoints	Progression-free survival (PFS)
Secondary Endpoints	Objective remission rate (ORR), overall survival (OS), disease control rate (DCR), and duration of disease remission (DOR)
Population	Patients with hepatocellular carcinoma exhibiting oligometastases/oligoprogression after first-line systemic therapy
Intervention Model	Multicenter, single-arm
Estimated Duration of Study	A total of 36 patients, 12 months enrollment, 60 months follow-up.