Trial results for the Phase 2 study (NCT03316872) investigating pembrolizumab in combination with stereotactic body radiotherapy (SBRT) for advanced hepatocellular carcinoma were posted on ClinicalTrials.gov on 2025-07-25. The study reported an overall response rate of 41% in patients who had progressed after sorafenib treatment.
Background
The study investigated pembrolizumab in patients with advanced hepatocellular carcinoma (HCC). These patients had previously experienced disease progression after treatment with sorafenib.
Trial design
The study (NCT03316872) was a Phase 2 trial with an enrollment of 18 participants. It investigated the combination of pembrolizumab and stereotactic body radiotherapy (SBRT) in patients with hepatocellular carcinoma. The trial's overall status is TERMINATED.
Key results
Key measurements from the trial included:
- The Overall Response Rate for the Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) group was 41% (percentage of participants).
- Median Progression-free Survival for the Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) group was 0.45 years.
- Median Overall Survival Rate for the Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) group was 1.05 years.
What this means
The results from this Phase 2 study suggest that the combination of pembrolizumab and stereotactic body radiotherapy (SBRT) may offer clinical activity in patients with advanced hepatocellular carcinoma who have progressed after sorafenib. The observed overall response rate of 41%, median progression-free survival of 0.45 years, and median overall survival of 1.05 years provide initial insights into this combination therapy for a challenging patient population. The study was terminated, and the small enrollment of 18 participants means these findings should be interpreted with caution.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03316872, titled "Study of Pembrolizumab and Radiotherapy in Liver Cancer," were posted on 2025-07-25 on clinicaltrials.gov.