Clinical trial NCT06763640: Prognostic Value of TIL in Nasopharyngeal Carcinoma
Official title: Prognostic Value of Deep Learning-Derived Tumor-Infiltrating Lymphocyte Percentage in Nasopharyngeal Carcinoma: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nasopharyngeal Carcinoma (NPC)
Keywords: nasopharyngeal carcinoma
digital pathology images
deep learning
tumor-infiltrating lymphocytes
metastatic risk
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Jiangxi Cancer Hospital

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: 3 Years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 Years
measure: Distant Metastasis-free Survival
timeFrame: 3 Years
measure: Locoregional Recurrenc-free Survival
timeFrame: 3 Years
measure: Objective Response Rate
timeFrame: During induction chemotherapy (up to 3 months)
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
Study officials:
References: