Enrolling by invitation NCT06763640
Prognostic Value of TIL in Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma (NPC). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prognostic Value of Deep Learning-Derived Tumor-Infiltrating Lymphocyte Percentage in Nasopharyngeal Carcinoma: a Prospective Observational Study
Overview
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.
Primary outcome measures
- Disease Free Survival (DFS) [Time frame: 3 Years]
Secondary outcome measures (4)
- Overall Survival [Time frame: 3 Years]
- Distant Metastasis-free Survival [Time frame: 3 Years]
- Locoregional Recurrenc-free Survival [Time frame: 3 Years]
- Objective Response Rate [Time frame: During induction chemotherapy (up to 3 months)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Jiangxi Cancer Hospital — Nanchang
Identifiers
NCT: NCT06763640 · SKJP1320241975