Using SAA1 levels to predict rapid tumor growth in cancer patients receiving immunotherapy
A Prospective Cohort Study of Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
This study is testing if measuring SAA1 levels in cancer patients can help predict who might experience rapid tumor growth when starting immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 374 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT06276088 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify high-risk cancer patients who may experience hyperprogression when treated with immune checkpoint inhibitors. By analyzing plasma and tissue samples, researchers will evaluate the levels of SAA1, a potential biomarker for predicting hyperprogression across various cancer types. The study will involve multiple centers and focus on patients diagnosed with specific malignancies who are about to start immunotherapy. The goal is to establish SAA1 as a reliable predictor of hyperprogression, which could help in early intervention and treatment planning.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific types of cancer who are about to begin treatment with immune checkpoint inhibitors.
Not a fit: Patients with contraindications to immunotherapy or those with serious coexisting medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier identification of patients at risk for hyperprogression, potentially improving treatment outcomes and quality of life.
How similar studies have performed: While the approach of using biomarkers to predict treatment responses is common, the specific focus on SAA1 for hyperprogression in immunotherapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 4 other locations
- Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (Recruiting)
- Fujian Provinical Hospital — Fuzhou, China (Not_yet_recruiting)
- Huizhou Central People's Hospital — Huizhou, China (Not_yet_recruiting)
- Jieyang people's hospital — Jieyang, China (Not_yet_recruiting)
- Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou, China (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.