Prognostic Value of TIL in Nasopharyngeal Carcinoma

• Conditions: Nasopharyngeal Carcinoma (NPC)

• Registration Number: NCT06763640
• Lead Sponsor: Jiangxi Provincial 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-25
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 Years	Overall Survival was defined as the interval from the date of diagnosis to the date of death for any cause
Distant Metastasis-free Survival	3 Years	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
Locoregional Recurrenc-free Survival	3 Years	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
Objective Response Rate	During induction chemotherapy (up to 3 months)	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)

Trial Locations

Locations (1)

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China