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Recruiting NCT06248554

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

Trial Parameters

Condition Hepatocellular Carcinoma
Sponsor Chen Xiaoping
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2019-12-01
Completion 2024-12-31
Interventions
PD-1 Inhibitors

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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

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