Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma

Prognostic Performance of Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma: a Prospective Multi-Center Observational Study

This study aims to conduct a prospective cohort study to validate the prognostic performance of Tertiary Lymphoid Structures (TLSs) as a predictive marker in pathological tissue sections for nasopharyngeal carcinoma (NPC). The TLS assessment framework established in this research has the potential to serve as a reference for personalized treatment strategies in NPC patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Cancinoma (NPC)

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Stage II-III Nasopharyngeal Carcinoma

Description

Inclusion Criteria:

1. Histopathological confirmed diagnosis of nasopharyngeal carcinoma (NPC).
2. No evidence of distant metastasis at initial treatment, with staging classified as II-III (AJCC 9th edition).
3. Patients aged 18-75 with a Karnofsky Performance Status (KPS) score ≥ 80.

4. Organ Function: Adequate organ function meeting the following criteria:

   • Hematology:

   White blood cell count > 3.0 × 10⁹/L. Absolute neutrophil count (ANC) > 1.5 × 10⁹/L. Hemoglobin (Hb) > 90 g/L. Platelet count > 100 × 10⁹/L. Albumin ≥ 3 g/dL.

   >Liver Function: Bilirubin ≤ 1.5 × the upper limit of normal (ULN); patients with Gilbert's syndrome may enroll if serum bilirubin ≤ 3 × ULN.

   Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; for patients with liver metastasis, AST/ALT ≤ 5 × ULN.

   Alkaline phosphatase (ALP) ≤ 3 × ULN; for patients with liver or bone metastasis, ALP ≤ 5 × ULN.

   >Coagulation Function: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

   >Renal Function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min as calculated by the Cockcroft-Gault formula (see Appendix 8).

5. Patients willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures.
6. Willing to adhere to study arrangements and refrain from participating in any other clinical trials related to drugs or medical devices during the study period.
7. Signed a formal informed consent form, indicating that they understand and agree to participate in the study in compliance with hospital policies.
8. Sufficient tumor tissue stored in paraffin blocks, suitable for scientific research purposes.

Exclusion Criteria:

1. Patients with concurrent malignant tumors other than nasopharyngeal carcinoma.
2. Patients with a history of severe immediate allergic reactions to any drug used in this study.
3. Patients who lack legal capacity or have limited legal capacity.
4. Patients with a history of drug or alcohol abuse, or with physical or mental disorders, who, in the investigator's opinion, are unable to fully understand or comply with the study's procedures and potential complications.

5. Patients with other serious acute or chronic medical conditions, laboratory abnormalities, or mental disorders that may increase the risk of treatment-related adverse events, interfere with the interpretation of study results, or make them unsuitable for participation in the study, as determined by the investigator. These include, but are not limited to:

   Autoimmune colitis, inflammatory bowel disease, noninfectious pneumonitis, pulmonary fibrosis;

6. Mental disorders such as dementia, epilepsy, or recent (within the past year) or active suicidal ideation or behavior.
7. Patients with a prior diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.
8. Pregnant or breastfeeding women, and male or female patients of childbearing potential who are unwilling or unable to use effective contraception throughout the study period and for at least one year after completing the treatment regimen.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
TLS positive; Positive TLS in Tumor
TLS negative; no TLS in Tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival	DFS is defined as the time from the date of enrollment to the first occurrence of either disease progression (as confirmed by imaging or clinical evaluation) or death from any cause, whichever occurs first. For patients without these events, DFS is censored at the time of the last follow-up.	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	OS is defined as the time from the date of enrollment to death from any cause, or the time interval to the last follow-up for patients who are alive at the end of the study.	3 Years
Locoregional Recurrenc-free Survival	LRRFS is defined as the time from the date of enrollment to the first occurrence of locoregional relapse (confirmed by imaging or clinical evaluation), or the time interval to the last follow-up for patients without locoregional relapse.	3 Years
Distant Metastasis-Free Survival	DMFS is defined as the time from the date of enrollment to the first occurrence of distant metastasis (confirmed by imaging or clinical evaluation), or the time interval to the last follow-up for patients without distant metastasis.	3 Years

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Outcome; Tertiary Lymphoid Structures; nasopharyngeal carcinom
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Tertiary Lymphoid Structures
• Other Study ID Numbers: TLS-NPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No