Sep 30

SS 36 - GI 3: Liver - Checking in on Inhibitors, inSPECTing Liver Function, and Making Progress Oligo-ly

308 - Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-Line Immunotherapy: A Phase II Clinical Study

01:05pm - 01:15pm PT

Room 22/23

Presenter(s)

Shisuo Du, MD, PhD - Zhongshan Hospital Fudan University, Shanghai 200032, Shanghai

S. J. Hsu¹, Y. Chao², S. Wang¹, Q. Zheng¹, Y. Zhang¹, Y. Hu¹, R. Chen³, Z. C. Zeng¹, and S. Du¹; ¹Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, China, ²Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China, Shanghai, China, ³Department of Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China

Purpose/Objective(s):

Immune checkpoint inhibitors (ICIs) have significantly improved the survival outcomes of liver cancer patients. However, a considerable proportion of patients eventually experience disease progression due to the development of resistance. Among these, oligoprogression is a common manifestation, occurring in 10-55.3% of advanced cancer patients. Local therapy, especially radiotherapy (RT), has been increasingly considered in the setting of oligoprogression to overcome ICIs resistance and delay the need to change systemic therapy. Therefore, this study aimed to explore the efficacy and safety of radiotherapy in oligoprogressive patients following first-line ICIs treatment.

Materials/Methods:

This single-arm, single-center, phase ? trial was conducted to evaluate the use of salvage radiotherapy in oligoprogressive metastatic HCC patients who had received first-line ICIs and developed progression of = 5 metastases. RT was administered to the progressing lesions while maintaining the original systemic therapy. The primary endpoint of the trial is progression-free survival (PFS).

Results:

A total of 35 patients treated between July 2022 and March 2023 were included, with a median follow-up of 24.4 months. The overall response rate (ORR) and disease control rate (DCR) were 74.3% and 91.4%, respectively. The median PFS was 11.3 months (95% CI 5.564-16.969). Median overall survival (OS) was not reached during the study period, with 6-month, 1-year, and 2-year OS rates of 100%, 88.4%, and 84.9%, respectively. The most frequent adverse events (AEs) were fatigue, decreased appetite, rash, fever, and nausea, all of which were reversible and manageable.

Conclusion:

ICIs re-challenge in combination with RT in patients with local oligoprogression demonstrated significant survival benefits. Its favorable safety profile supports its integration into personalized treatment sequencing. A prospective randomized trial is ongoing to further validate this finding (ChiCTR2200060664).