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Recruiting NCT06248554

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

No phase Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 Inhibitors.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

  • Drug 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

Primary outcome measures

  • Disease-free survival [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 outcome measures (2)
  • Overall survival [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 [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wu — Wuhan

Identifiers

NCT: NCT06248554 · HOPE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗