Postoperative Adjuvant Therapy of HCC Based on PD-1

Chen Xiaoping

Status and phase: Completed; Phase 2; Phase 1

Conditions: RFS; Hepatocellular Carcinoma

Treatments: Drug: PD-1 inhibitors; Procedure: TACE

Study type: Observational

Funder types: Other

Identifiers

NCT05307926

Y-D202001-0289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 573 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

573 participants in 2 patient groups

PD-1 based therapy cohort

Description:

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.

Treatment:

Drug: PD-1 inhibitors

TACE cohort

Description:

Patients who received 1 TACE about a month after the operation were included in the control cohort.

Treatment:

Procedure: TACE