Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

Carcinoma, Hepatocellular Clinical Trial

Official title: An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of Adebrelimab Plus Apatinib as Adjuvant Therapy in Participants With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection

Status Recruiting

Clinical Trial Summary

This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.

Clinical Trial Description

Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection.

Adebelimumab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can specifically bind to PD-L1 molecules to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance, reactivate the anti-tumor activity of the immune system, and achieve the goal of treating tumors. As of October 8, 2021, adebelimumab has conducted several clinical studies in various malignant tumor fields and has shown good anti-tumor efficacy and controllable safety.

Therefore, we plan to conduct a prospective clinical study targeting HCC patients at high risk of postoperative recurrence, to demonstrate the efficacy and safety of postoperative adjuvant therapy with adebelimumab combined with apatinib. This study has the potential to provide efficient new treatment options for patients, which is of great significance for improving the survival rate and quality of life of liver cancer patients in general.

A mid-term analysis will be conducted on the recurrence free survival rate and survival rate, at 6 months after the enrollment of 30 patients. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Recurrence

• NCT number: NCT06454578
• Study type: Interventional
• Source: Qilu Hospital of Shandong University
• Contact: Tao Li, Dr
• Phone: +86-18560085138
• Email: Litao7706@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2024
• Completion date: June 2027