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
Chen Xiaoping
200 participants
Dec 1, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Aged 18-75 years
- Pathological type is HCC, BCLC stage 0-A
- No extrahepatic HCC
- No radiographic recurrence at 2-4 weeks after ablation
- Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
- Child-Pugh grade A or B and adequate hematologic and organ function
Exclusion Criteria7
- Any history of other malignant tumors or recurrent HCC
- Any preoperative treatment for HCC including local and systemic therapy
- Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- Any persistent serious ablation-related complications
- Esophageal and/or gastric variceal bleeding within 6 months
- Inability or refusal to comply with the treatment and monitoring
- Participation in other clinical trials
Interventions
Patients in the intervention group received post-operative adjuvant PD-1 inhibitor therapy, 240 mg intravenously every three weeks for nine cycles
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06248554