Prognostic Value of TIL in Nasopharyngeal Carcinoma

NCT06763640 | Enrolling By Invitation

• 1 other identifier: SKJP1320241975
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

nasopharyngeal carcinoma; digital pathology images; deep learning; tumor-infiltrating lymphocytes; metastatic risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

  3 Years

• Distant Metastasis-free Survival

  3 Years

• Locoregional Recurrenc-free Survival

  3 Years

• Objective Response Rate

  During induction chemotherapy (up to 3 months)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Jiangxi Cancer Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

CN (1)