Combined Immunotherapy and Targeted Therapy for Advanced Liver Cancer

Advanced Liver Cancer Clinical Trial

Official title: Study on Combined Immunotherapy and Targeted Therapy for Advanced Liver Cancer

Status Recruiting

Clinical Trial Summary

Liver cancer is a common malignant tumor in China, and its incidence rate ranks third and remains high. The treatment of liver cancer has made some progress in recent years, mainly the progress of radical treatment such as surgery and ablation. For liver cancer, due to the emergence of molecularly targeted drugs such as sorafenib and immunological checkpoint inhibitors, the systemic therapeutic effect of advanced liver cancer is improved, and the curative effect is further improved. In recent years, immunotherapy has become one of the clinical treatment options for cancer. T lymphocytes are a cell with cell killing ability in the immune system, and programmed death factor 1 (PD-1) is an important inhibitory receptor on the surface of T lymphocytes. It is known that the ligands of PD-1 are PD-L1 and PD-L2, and studies have found that a variety of tumor cells have high expression of PD-L1 ligand on the surface. At present, clinical research on target drugs for PD-1 has included dozens of solid tumors or hematological tumors. The results of clinical studies that have been completed and the interim results of some studies indicate that anti- PD-1 antibody drugs are more effective and safer than previous treatments. Patients with hepatocellular carcinoma (HCC) often undergo liver cancer resection, but the recurrence rate can reach 70% to 100%, which seriously affects the treatment outcome and long-term survival rate. Early recurrence of liver cancer is mainly related to the invasiveness of the tumor. Microvascular invasion, non-anatomical hepatectomy, AFP greater than 32 ng/ml, tumor diameter greater than 5 cm, and incomplete tumor capsule are risk factors for recurrence within 2 years after surgery. Hence, it is necessary to determine the risk factors for HCC recurrence and the markers for continuous monitoring of anti-tumor response before and after surgery. Circulating tumor cells (CTCs) is an integral part of "liquid biopsy" and has great potential to change the current treatment modality in the cancer field. CTCs are derived from solid tumors and are associated with hematogenous metastasis. Therefore, analyzing the level of CTC has clinical guiding significance. For liver cancer patients, overall survival (OS) tended to be poorer in patients with CTCs. Although surgical treatment of liver cancer has benefited most patients with liver cancer, monitoring postoperative recurrence, further improving the long-term prognosis of liver cancer, postoperative detection of CTCs and other related indicators, combined with targeted, immune and other related treatments for further study. It is expected to receive 100 patients (50 treatment groups, 50 control groups). Patients who underwent immunotherapy after surgery were assigned to the immunotherapy group, and patients who were not treated with sorafenib after surgery were classified as the control group. All patients underwent 7 CTCs tests (immunomagnetic beads negative enrichment-targeted PCR) before, 7 days after surgery and 1st, 3rd, 6th, 9th, and 12th postoperatively. All patients were observed from the observation period. After the liver cancer resection, the patient was observed to have died, lost to follow-up or the end of the study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Liver Cancer
• Liver Neoplasms

• NCT number: NCT04163237
• Study type: Interventional
• Source: Guangxi Medical University
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2019
• Completion date: November 30, 2020