Postoperative Adjuvant Therapy of HCC Based on PD-1

• Status: Active, not recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

To Hepatocellular carcinoma (HCC), radical resection is still one of the best treatments for HCC, 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 (PVTT) and microvascular invasion (MVI) is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. Immune checkpoint inhibitors(such as PD1) may improve the prognosis of these patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chen Xiaoping
• Treatments: Immune Checkpoint Inhibitors; Lenvatinib

Criteria

Inclusion Criteria:

• 1. HCC with high-risk factors for tumor recurrence, including tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion (MVI), portal vein thrombosis (PVTT), and poorly differentiated.

• 2. Age: 18-75 years old

• 3. The pathological type was HCC; R0 excision and there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain

• 4. Without surgical contraindications such as other heart and lung diseases; the ECOG0-1 score

• 5. The preoperative Childpugh of liver function was AorB grade

• 6. No severe cirrhotic portal hypertension

• 7. The patient knows and agrees

Exclusion Criteria:

• 1. Complicated with other malignant tumors, recurrent HCC

• 2. Received preoperative chemotherapy, targeted therapy, and other neoadjuvant therapy

• 3. Suffering from active thyroid disease, acute or active infectious diseases;

• 4. There are serious underlying diseases and continuous surgery-related complications;

• 5. Allergic to PD1 or targeted drugs;

• 6. Inability or refusal to comply with the treatment and monitoring required by the study