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

Chen Xiaoping251 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

251

Conditions

Hepatocellular Carcinoma

Interventions

PD-1 InhibitorsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Wuhan, China

Outcomes

Primary Outcomes

Disease-free survival

Disease-free survival was defined as the period from inclusion in the study until tumor recurrence, death from any cause.

Time frame: 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

Secondary Outcomes

Overall survival

Overall survival was defined as the period from study inclusion until death from any cause.

Time frame: 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

Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.

Time frame: 6 months

Data from ClinicalTrials.gov

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