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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Disease-free survival [Срок оценки: From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months]

Вторичные конечные точки (2)

• Overall survival [Срок оценки: From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months]
• Adverse effects [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wu — Ухань

Идентификаторы

NCT: NCT06248554 · HOPE-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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