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

Recruiting

• Conditions: Immunotherapy; Hyperprogression; Biomarker

• Registration Number: NCT06276088
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-18
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

1. Over 18 years of age
2. Voluntarily sign informed consent
3. The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer, bladder cancer and other malignant tumors
4. Need to be treated with immune checkpoint inhibitors
5. ECOG PS Score: 0/1.

Exclusion Criteria

1. There are contraindications to immunotherapy
2. Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External)
3. Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
4. At the investigator's discretion, those who was not considered to be suitable for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hyperprogression	2 years	Incidence of hyperprogression will be calculated.

Secondary Outcome Measures

Name	Time	Method
Event-free survival	3 years	Event-free survival was defined as the time from the date of inclusion until hyperprogression or death from any cause.
Progression-free survival	3 years	Progression-free survival was defined as the time from the date of inclusion until disease progress or death from any cause.
Overall survival	3 years	Overall survival was defined as the time from the date of inclusion until death from any cause.

Trial Locations

Locations (5)

Jieyang people's hospital; 🇨🇳 Jieyang, China

Huizhou Central People's Hospital; 🇨🇳 Huizhou, China

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou; 🇨🇳 Meizhou, China

Nanfang hospital, Southern medical university; 🇨🇳 Guangzhou, Guangdong, China

Fujian Provinical Hospital; 🇨🇳 Fuzhou, China