Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, Adjuvant therapy, Microwave ablation, PD-1 inhibitor
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.
Interventions
DRUGPD-1 Inhibitors
Patients in the intervention group received post-operative adjuvant PD-1 inhibitor therapy, 240 mg intravenously every three weeks for nine cycles
Sponsors
Chen Xiaoping
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
STUDY_DIRECTORWanGuang D Zhang
Tongji Hospital
Outcome results
None listed