Prognostic Value of TIL in Nasopharyngeal Carcinoma

Prognostic Value of Deep Learning-Derived Tumor-Infiltrating Lymphocyte Percentage in Nasopharyngeal Carcinoma: a Prospective Observational Study

Our center plans to conduct a prospective, multicenter, observational study aimed at observing the percentage of TIL infiltration calculated using deep learning methods based on digital pathological images, and analyzing its prognostic significance in nasopharyngeal carcinoma, in order to help guide personalized treatment.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nasopharyngeal Carcinoma (NPC)

• Study Type: Observational
• Enrollment (Estimated): 216

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: Non-Probability Sample

Study Population

Jiangxi Cancer Hospital

Description

Inclusion Criteria：

• Histopathology confirms nasopharyngeal carcinoma;
• At the initial treatment, there was no evidence of distant metastasis, and the staging was II-III (AJCC 9th);
• Age range of 18-70 years old, KPS ≥ 80 points;
• Having good organ function; The following conditions must be met: Hematology: White blood cell count>3.0 × 109/L; Absolute neutrophil count (ANC)>1.5 × 109/L; Hb>90g/L； Platelets>100 × 109/L; Albumin ≥ 3g/dL Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase (ALP) ≤ 3 times ULN • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; • Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60mL/min.
• Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures;
• Willing to comply with arrangements during the research period and cannot participate in any other clinical studies related to drugs and medical devices;
• Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies.
• Sufficient tissue stored in wax blocks suitable for scientific research use.

Exclusion Criteria:

• Merge with other malignant tumors
• Individuals with a history of severe immediate hypersensitivity to any medication used in this study
• No capacity for civil conduct or limited capacity for civil conduct;
• Abuse of drugs or alcohol addiction, patients with physical or mental illnesses, and those deemed by the researchers to have a complete or thorough understanding of the possible complications of this study;
• Other serious acute or chronic medical conditions (including immune-mediated colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illnesses (including dementia and epilepsy, recent, past year, or active suicidal ideation or behavior) that may increase the risks associated with the study protocol treatment, or may interfere with the interpretation of study results and (based on the researcher's judgment) make patients unsuitable for participation in this study, or laboratory test abnormalities;
• Previously diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases;
• Pregnant or lactating female patients, male or female patients who have fertility but are unwilling or unable to use contraception for at least one year throughout the study period and after the end of the treatment plan.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival (DFS)	DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival was defined as the interval from the date of diagnosis to the date of death for any cause	3 Years
Distant Metastasis-free Survival	DMFS was defined as the interval from the date of diagnosis to the data of distant metastases or censored at the date of last follow-up	3 Years
Locoregional Recurrenc-free Survival	LRRFS was defined as the interval from the date of diagnosis to the data of locoregional recurrence or censored at the date of last follow-up	3 Years
Objective Response Rate	Objective response rate is defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST1.1)	During induction chemotherapy (up to 3 months)

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: January 7, 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: nasopharyngeal carcinoma; deep learning; tumor-infiltrating lymphocytes; digital pathology images; metastatic risk
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma
• Other Study ID Numbers: SKJP1320241975

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