Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: PD-1 Inhibitors
- Registration Number
- NCT06248554
- Lead Sponsor
- Chen Xiaoping
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD-1 inhibitor adjuvant therapy group PD-1 Inhibitors Received adjuvant PD-1 inhibitor 2-4 weeks after microwave surgery for a total of 9 cycles of treatment
- Primary Outcome Measures
Name Time Method Disease-free survival 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 Outcome Measures
Name Time Method 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 Overall survival was defined as the period from study inclusion until death from any cause.
Adverse effects 6 months Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
🇨🇳WuHan, China