NCT04639284

Anti-angiogenic Agents Plus Anti-PD-1 Antibodies for uHCC

Combination Therapy With Anti-angiogenic Agents and Anti-PD-1 Antibodies for Unresectable or Advanced Hepatocellular Carcinoma: a Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Combination treatment with antiangiogenic agents and anti-programmed cell death protein 1 (PD-1) antibodies have shown high anti-tumor efficacy for patients with unresectable or advanced hepatocellular carcinoma (uHCC). In this single-center cohort study, we are aiming to (1) evaluate the clinical effectiveness in real-world patients, especially for Chinese patients, most of whom were with hepatitis B virus infection; (2) predict clinical effectiveness with clinicopathological features; (3) predict clinical effectiveness with histologic features and blood samples.

Detailed description

Combination treatment with antiangiogenic agents and anti-programmed cell death protein 1 (PD-1) antibodies have shown high anti-tumor efficacy for patients with unresectable or advanced hepatocellular carcinoma (uHCC). In this single-center cohort study, we are aiming to: 1. To evaluate the clinical effectiveness in real-world patients, especially for Chinese patients most of whom were with hepatitis B virus infection. 2. To predict clinical effectiveness with clinicopathological features, such as lab examinations (at baseline and dynamic changes), radiological features (radiomics study at the baseline); 3. To predict clinical effectiveness with histologic features, such as PD-L1 expression, ctDNA, and peripheral immune cell subtypes. 4. To evaluate the clinical effectiveness of second- or third-line therapies, including TACE, HAIC, and interferon, for those who lost clinical benefit or who were intolerant to the combination therapy.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Anti-angiogenic agents plus anti-PD-1/PD-L1 antibodies	Combination therapies with an anti-angiogenic agent (tyrosine kinase inhibitor or VEGF/VEGFR antibody) and an anti-PD-1/PD-L1 antibody.

Timeline

• Start date: 2020-12-23
• Primary completion: 2022-07-31
• Completion: 2023-07-31
• First posted: 2020-11-20
• Last updated: 2021-07-26

Locations

1 site across 1 country: China