Hepatocellular Carcinoma, RFS
Conditions
Keywords
PD-1, Disease-free survival rate, adjuvant therapy, Lenvatinib
Brief summary
For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.
Detailed description
We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.
Interventions
DRUGPD-1 inhibitors
For patients with PVTT, they received adjuvant therapy of PD1 (200mg intravenously every 3 weeks for a total of 18cycles) plus Lenvatinib (8mg orally once a day for 1 year) 2-4 weeks after surgery; for patients with other high-risk factors for recurrence, they PD-1(200mg intravenously every 3 weeks for a total of 9cycles) monotherapy 2-4 weeks after surgery.
PROCEDURETACE
Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.
Sponsors
Chen Xiaoping
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain * 2\. Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery * 3\. Aged18-75 * 4\. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 * 5\. Child-Pugh grade A or B * 6\. The patient knows, and informed consent was obtained
Exclusion criteria
* 1\. Any history of other malignant tumors or recurrent HCC * 2\. Any preoperative treatment for HCC including local and systemic therapy * 3\. Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * 4\. Any persistent serious surgery-related complications * 5\. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months * 6\. Inability or refusal to comply with the treatment and monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | From date of inclued 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 | The primary outcomes of this study include disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of inclued in this research until the date of death from any cause, assessed up to 60 months. | The secondary outcomes of this study include overall survival |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 12months | The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
Countries
China
Outcome results
None listed