The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC

Study Overview
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Brief Summary
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This study aims to explore the prognostic value of pathological remission after one cycle of induction chemotherapy in locally advanced nasopharyngeal carcinoma, and the change of immune micro-environment after one cycle induction chemotherapy, including the density of immune cells infiltration and tertiary lymphoid structures.

Official Title
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The Prognostic Value of the Degree of Pathological Response at One Cycle of Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinon-a Prospective Observational Study

Conditions
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Nasopharyngeal Carcinoma, Pathologic Complete Response, Tumor Microenvironment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to sign informed consent Age > 18 years at time of study entry Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study) Histological confirmation of NPC (regardless if EBER positive or negative) Locally advanced NPC, UICC stage III-IVa Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Exclusion Criteria: Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study Distant metastases Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC. History of another primary malignancy Female patients who are pregnant Known allergy or hypersensitivity to any drugs Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival (PFS) | PFS is defined as the time from treatment to date of first documentation of progression or death due to any cause. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from treatment to death, regardless of disease recurrence. | 3 years | 
| Distant metastasis-free survival (DMFS) | DMFS is defined as the time from diagnosis to the date of distant metastasis or when censored at the latest date. | 3 years | 
| Pathological complete response (pCR) rate | pCR is defined as the absence of residual invasive. | At the end of Cycle 1 (each cycle is 21 days). | 
| Infiltrating Immune cell density | CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure | At the end of Cycle 1 (each cycle is 21 days). |