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

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.

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy; Biomarker; Hyperprogression

• Study Type: Observational
• Enrollment (Estimated): 374

Contacts and Locations

Study Locations

• China
  • Fuzhou, China
    • Not yet recruiting
    • Fujian Provinical Hospital
    • Contact: Yongmei Dai
  • Huizhou, China
    • Not yet recruiting
    • Huizhou Central People's Hospital
    • Contact: Yunming Tian
  • Jieyang, China
    • Not yet recruiting
    • Jieyang People's Hospital
    • Contact: Peibao Lai
  • Meizhou, China
    • Not yet recruiting
    • Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
    • Contact: Jianda Sun
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Jian Guan, M.D.; Phone Number: 86+13632102247; Email: guanjian5461@163.com
      • Principal Investigator: Jian Guan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Cancer patients who need to accept immunotherapy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hyperprogression	Incidence of hyperprogression will be calculated.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall survival	Overall survival was defined as the time from the date of inclusion until death from any cause.	3 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Pan-cancer; SAA1; Hyperprogression
• Other Study ID Numbers: NFEC-2024-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No