Postoperative Adjuvant Therapy of HCC Based on PD-1

Completed

• Conditions: RFS; Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Drug: PD-1 inhibitors

• Registration Number: NCT05307926
• Lead Sponsor: Chen Xiaoping

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TACE cohort	TACE	Patients who received 1 TACE about a month after the operation were included in the control cohort.
PD-1 based therapy cohort	PD-1 inhibitors	Patients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	12months	The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
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

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China