Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation: a Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Disease-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PD-1 inhibitor adjuvant therapy group
Received adjuvant PD-1 inhibitor 2-4 weeks after microwave surgery for a total of 9 cycles of treatment
Intervention: PD-1 Inhibitors (Drug)
Control group
Receive regular monitoring and follow-up
Outcomes
Primary Outcomes
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
Disease-free survival was defined as the period from inclusion in the study until tumor recurrence, death from any cause.
Secondary Outcomes
- Overall survival(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(6 months)
Investigators
Chen Xiaoping
professor
Tongji Hospital