NCT06248554

Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation

Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation: a Prospective Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chen Xiaoping · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy.

Detailed description

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy. There is no consensus on postoperative adjuvant therapy, especially for the management of early-stage HCC. Most scholars believe that HCC in this period does not have high-risk factors for tumor recurrence, thus neglecting the role of adjuvant therapy. Early studies have found that microwave ablation can alter the tumor microenvironment, which is conducive to the action of immune checkpoint inhibitors such as PD-1 inhibitors and even has a synergistic anti-tumor effect. We therefore designed this prospective cohort study to explore the efficacy and safety of adjuvant PD-1 inhibitors after microwave surgery.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	PD-1 Inhibitors	Patients in the intervention group received post-operative adjuvant PD-1 inhibitor therapy, 240 mg intravenously every three weeks for nine cycles

Timeline

• Start date: 2019-12-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-02-08
• Last updated: 2025-12-02

Locations

1 site across 1 country: China