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

NCT07147361 | Active Not Recruiting

• 1 other identifier: NCC5443
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC); Cervical Squamous Cell Carcinoma; Lung Squamous Cell Carcinoma; Head and Neck Squamous Carcinoma

Outcome Measures

Primary Outcomes (1)

• Area under ROC curve

  From enrollment to the end of two treatment cycles (each cycle is 28 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study enrolls patients with confirmed squamous cell carcinoma (SCC), including esophageal, head/neck, cervical, and lung subtypes, regardless of resectability. Participants must be scheduled for neoadjuvant or first-line PD-1 inhibitor therapy and provide pretreatment tumor and blood samples. Key inclusion requires capacity for informed consent; concurrent malignancies or prior anticancer treatments are exclusions. All subjects must provide written informed consent and undergo baseline assessments: clinical data collection, archival/fresh tumor tissue acquisition (within 6 months), and peripheral blood sampling (within 28 days) for biomarker analysis.

You may qualify if:

• Patients with pathologically confirmed esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), cervical squamous cell carcinoma (CSCC), or lung squamous cell carcinoma (LSCC), regardless of surgical eligibility
• For surgically eligible patients: Planned to receive neoadjuvant PD-1 inhibitor ± chemotherapy as first-line treatment
• For surgically ineligible patients: Planned to receive PD-1 inhibitor ± chemotherapy as first-line treatment
• Availability of pre-treatment biopsy tissue and baseline blood samples
• Capable of providing informed consent

You may not qualify if:

• Patients with concurrent other types of malignancies
• Patients who have already undergone prior antitumor therapy

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Department of Etiology and Carcinogenesis

Beijing, Beijing Municipality, 100021, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

① Tissue samples: To collect residual pre-treatment biopsy tissue samples from enrolled individuals, which are left over from routine clinical diagnosis and treatment. ② Blood samples: To collect residual blood samples from enrolled individuals, which are left over from routine clinical diagnosis and treatment.

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Department of Etiology and Carcinogenesis

  Cancer Hospital Chinese Academy of Medical Scienc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 29, 2025
• Study Start: April 28, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (1)