Postoperative Adjuvant Therapy of HCC Based on PD-1

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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RFS, Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: PD-1 inhibitors
* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD-1 based therapy cohort<br>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. | Drug: PD-1 inhibitors<br>* 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.<br>* Other names: Lenvatinib;|
| TACE cohort<br>Patients who received 1 TACE about a month after the operation were included in the control cohort. | Procedure: TACE<br>* Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | The primary outcomes of this study include 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The secondary outcomes of this study include overall survival | From date of inclued in this research until the date of death from any cause, assessed up to 60 months. | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-1, Disease-free survival rate, adjuvant therapy, Lenvatinib