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

Immunotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276088
• Other study ID #: NFEC-2024-067
• Status: Recruiting
• Start date: February 18, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Est. completion date: October 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarker
• Immunotherapy

Locations

Country	Name	City	State
China	Fujian Provinical Hospital	Fuzhou
China	Nanfang hospital, Southern medical university	Guangzhou	Guangdong
China	Huizhou Central People's Hospital	Huizhou
China	Jieyang people's hospital	Jieyang
China	Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou	Meizhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hyperprogression	Incidence of hyperprogression will be calculated.	2 years
Secondary	Event-free survival	Event-free survival was defined as the time from the date of inclusion until hyperprogression or death from any cause.	3 years
Secondary	Progression-free survival	Progression-free survival was defined as the time from the date of inclusion until disease progress or death from any cause.	3 years
Secondary	Overall survival	Overall survival was defined as the time from the date of inclusion until death from any cause.	3 years