Prognostic Value of TIL in Nasopharyngeal Carcinoma

NCT ID: NCT06763640

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

SKJP1320241975

Identifier Type: -

Identifier Source: org_study_id