Clinical Research Directory

Predictive Biomarkers for PD-1 Inhibitor Response in Squamous Cell Carcinoma

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Summary

This study is a multicenter cohort investigation integrating both retrospective and prospective components, designed to evaluate the predictive performance of combined blood ELISA testing and tissue multiplex immunofluorescence (mIF) staining for assessing treatment response to PD-1 inhibitors in patients with squamous cell carcinoma. The retrospective cohort will analyze clinical data and pretreatment specimens (tissue biopsies and blood samples) from SCC patients who received PD-1 inhibitor therapy between April 2022 and June 2025 across participating centers. Using the combined blood ELISA and tissue mIF approach, the investigators will develop a predictive model to stratify patients into different response groups, then evaluate clinical outcomes including objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS) to preliminarily validate the model's feasibility. The prospective cohort will enroll 800 participants in a multicenter setting, stratified according to the predictive model developed from the retrospective analysis. Key stratification factors include: 1) high risk of treatment resistance based on combined blood ELISA and tissue mIF scoring; and 2) low risk of treatment resistance based on the same evaluation system. The study consists of baseline and follow-up phases. During the baseline phase, eligible subjects who provide informed consent will undergo comprehensive clinical data collection. Tumor specimens (archived formalin-fixed paraffin-embedded blocks or fresh biopsy slides obtained within the preceding 6 months) and blood samples (collected within 28 days) will be processed for blood ELISA and tissue mIF analysis to categorize patients into high-risk and low-risk groups. The follow-up phase involves longitudinal monitoring of treatment response, including documentation of therapeutic regimens (drugs, dosages, cycles), scheduled clinical evaluations at weeks 4, 8, and 12 post-treatment (capturing medical history updates, radiographic findings, and physician-assessed ORR), and quarterly survival status updates via telephone until disease progression, death, loss to follow-up, consent withdrawal, initiation of alternative therapies, or study termination.

Official title: Biomarkers for Predicting Response to PD-1 Inhibitor Therapy in Squamous Cell Carcinoma: A Retrospective-Prospective Cohort Study

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