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Exploratory Study on SERPINE1 Expression in Peripheral Blood as a Biomarker for Treatment Response and Prognosis in Head and Neck Squamous Cell Carcinoma

Exploratory Study on SERPINE1 Expression in Peripheral Blood as a Biomarker for Treatment Response and Prognosis in Head and Neck Squamous Cell Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121745
Enrollment
Unknown
Registered
2026-04-02
Start date
2026-04-03
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck squamous cell carcinoma

Interventions

head and neck squamous cell carcinoma Cohort:None

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent; 2: Age >= 18 years old; 3. Head and neck squamous cell carcinoma confirmed by histopathology or cytology, including oral cancer, oropharyngeal cancer's disease, hypopharyngeal cancer, laryngeal cancer, etc. (excluding nasopharyngeal cancer); 4. Clinical stages are III-IVB(HPV negative oropharyngeal cancer and other HNSCC)(AJCC, 8th edition), II-III(HPV positive oropharyngeal cancer) (AJCC, 8th edition), and recurrent or metastatic HNSCC; 5. Locally advanced patients have not received any anti-tumor treatment before, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. Recurrent or metastatic patients have not received systematic treatment for recurrent or metastatic diseases; 6. Locally advanced patients, patients with recurrence or metastasis all plan to receive immune combined chemotherapy; 7: ECOG score 0-2; 8. The functions of major organs and bone marrow are basically normal; 9: Measurable lesions (RECIST V1.1).

Exclusion criteria

Exclusion criteria: 1. Non-squamous cell carcinoma (such as adenocarcinoma, sarcoma and lymphoma), nasopharyngeal carcinoma and metastatic squamous cell carcinoma with unknown primary focus in head and neck; 2. Recently (within 4 weeks) received anti-tumor treatment or participated in other clinical trials; 3. Autoimmune diseases: Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.) require long-term use of immunosuppressants (such as glucocorticoids and biological agents); 4. Coagulation-related diseases: known coagulation dysfunction (such as hemophilia, hereditary thrombophilia, recent history of venous thromboembolism), or using anticoagulant drugs (such as warfarin and heparin) or antiplatelet drugs (such as aspirin and clopidogrel); 5. Abnormal blood system: known blood system diseases (such as anemia, leukopenia, thrombocytopenia); 6. Complicated with serious systemic diseases: severe heart, lung, liver and renal insufficiency (for example, ALT/AST > 3 times the normal upper limit, Cr > 1.5 times the normal upper limit), or active infection (such as HIV, active hepatitis and uncontrolled bacterial/fungal infection); 7. Complicated with other malignant tumors: having a history of other malignant tumors in the past 5 years (except non-melanoma skin cancer or cured cervical carcinoma in situ); 8: pregnant or lactating women; 9. Mental disorder or inability to cooperate with study follow-up; 10: The estimated survival time is less than 3 months.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
disease control rate;objective response rate;

Countries

China

Contacts

Public ContactWei Li

Beijing Tongren Hospital, Capital Medical University

vision988@126.com+86 158 1102 9005

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026