Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Over 18 years of age
Voluntarily sign informed consent
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
Need to be treated with immune checkpoint inhibitors
Disqualifiers
There are contraindications to immunotherapy
Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External)
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.
At the investigator's discretion, those who was not considered to be suitable for participation in the study.
Trial population
Cancer patients who need to accept immunotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of hyperprogression
Incidence of hyperprogression will be calculated.
Time frame
2 yearsSecondary outcomes
1
Event-free survival
Event-free survival was defined as the time from the date of inclusion until hyperprogression or death from any cause.
Time frame
3 years2
Progression-free survival
Progression-free survival was defined as the time from the date of inclusion until disease progress or death from any cause.
Time frame
3 years3
Overall survival
Overall survival was defined as the time from the date of inclusion until death from any cause.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov