Clinical trial NCT06276088: Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
Official title: A Prospective Cohort Study of Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunotherapy
Hyperprogression
Biomarker
Keywords: SAA1
Immunotherapy
Hyperprogression
Pan-cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients who need to accept immunotherapy

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of hyperprogression
timeFrame: 2 years
Secondary outcomes:
measure: Event-free survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern medical university
state: Guangdong
city: Fuzhou
country: China
facility: Fujian Provinical Hospital
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
city: Jieyang
country: China
facility: Jieyang people's hospital
city: Meizhou
country: China
facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Study officials:
References: