NCT06276088

Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy

A Prospective Cohort Study of Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 374 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients.

Conditions

• Immunotherapy
• Hyperprogression
• Biomarker

Timeline

• Start date: 2024-02-18
• Primary completion: 2025-12-31
• Completion: 2026-10-31
• First posted: 2024-02-23
• Last updated: 2024-03-15

Locations

5 sites across 1 country: China