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NCT Number: NCT06276088

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.

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Key information

Conditions

Immunotherapy Biomarker Hyperprogression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang hospital, Southern medical university, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • ECOG PS Score: 0/1.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence of hyperprogression

    Time frame: 2 years

    Incidence of hyperprogression will be calculated.

Secondary outcomes

  1. Event-free survival

    Time frame: 3 years

    Event-free survival was defined as the time from the date of inclusion until hyperprogression or death from any cause.

  2. Progression-free survival

    Time frame: 3 years

    Progression-free survival was defined as the time from the date of inclusion until disease progress or death from any cause.

  3. Overall survival

    Time frame: 3 years

    Overall survival was defined as the time from the date of inclusion until death from any cause.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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