NCT04204577

The Safety and Efficacy of Thermal Ablation Combined With Apatinib and Carilimub for Advanced Liver Cancer

Three-arm Open Parallel Control Phase II Trial for Evaluation of Thermal Ablation Combined With Apatinib and PD-1 Antibody SHR-1210 for Advanced Liver Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for the treatment of advanced liver cancer.

Detailed description

Primary liver cancer is a common malignant tumor in the world. Its pathogenesis is concealed and clinically asymptomatic. It is mostly in the middle and late stages of the disease. It is often combined with different degrees of cirrhosis. The liver function reserve is poor.About 80% of patients are in the first place. The operation has been lost at the time of diagnosis. Primary liver cancer is not sensitive to conventional treatments such as radiotherapy and chemotherapy because of its unique tissue type. For advanced liver cancer, ablation combined with other systemic treatments is expected to alleviate the patient's condition, prolong the patient's survival time, and benefit more patients. The long-term clinical efficacy of tumor thermal ablation has been reported more, the basic conclusion is consistent, hat is, the 5-year survival rate of early stage tumors such as liver cancer less than 3cm is not inferior to surgical resection, or even better. Liver cancer is rich in blood supply and tumor blood vessels are dense. The formation and maintenance of these blood vessels requires pro-angiogenic signals, of which VEGFR is a key component. Apatinib is a small molecule tyrosine kinase inhibitor that inhibits VEGFR at very low concentrations. SHR-1210 is a humanized anti-programmed cell death receptor 1 antibody. This study was designed to evaluate the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for the treatment of advanced liver cancer.

Conditions

• BCLC Stage B Hepatocellular Carcinoma
• BCLC Stage C Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate	Evaluation of the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for advanced liver cancer.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-11-01
• Completion: 2023-11-01
• First posted: 2019-12-19
• Last updated: 2019-12-19

Locations

1 site across 1 country: China