NCT05307926

Postoperative Adjuvant Therapy of HCC Based on PD-1

PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 573 (actual)
• Sponsor: Chen Xiaoping · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• RFS

Interventions

Type	Name	Description
DRUG	PD-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.
PROCEDURE	TACE	Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-07-30
• Completion: 2022-08-20
• First posted: 2022-04-01
• Last updated: 2022-09-07

Locations

1 site across 1 country: China