Using PD-1 inhibitors after microwave ablation for early-stage liver cancer
Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation: a Prospective Cohort Study
This study is testing if adding PD-1 inhibitors after microwave ablation can help people with early-stage liver cancer stay cancer-free longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT06248554 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of PD-1 inhibitors as an adjuvant therapy for patients with early-stage hepatocellular carcinoma (HCC) following microwave ablation. The aim is to evaluate the efficacy and safety of this treatment approach, as patients often experience early recurrence after ablation. The study focuses on patients who have undergone successful microwave ablation without signs of recurrence. By exploring the potential synergistic effects of PD-1 inhibitors on the tumor microenvironment altered by ablation, the research seeks to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with early-stage hepatocellular carcinoma who have undergone microwave ablation and show no signs of recurrence.
Not a fit: Patients with a history of other malignancies, recurrent HCC, or those with certain health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce the risk of recurrence in patients with early-stage liver cancer after microwave ablation.
How similar studies have performed: While there is limited consensus on adjuvant therapy for early-stage HCC, early studies suggest that combining microwave ablation with PD-1 inhibitors may have promising effects, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuhan
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China — Wuhan, China (Recruiting)
Study contacts
- Study coordinator: WanGuang D Zhang
- Email: wgzhang@tjh.tjmu.edu.cn
- Phone: +8613886195965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.