Clinical trial NCT06248554: Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation
Official title: Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Adjuvant therapy
Microwave ablation
PD-1 inhibitor
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Disease-free survival
timeFrame: 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:
measure: Overall survival
timeFrame: From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months
measure: Adverse effects
timeFrame: 6 months
Other outcomes:
Locations:
city: WuHan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Study officials:
affiliation: Tongji Hospital
name: WanGuang D Zhang
role: STUDY_DIRECTOR
References: