The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC
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, Pathologic Complete Response, Tumor Microenvironment. Basic parameters: from 18 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 →
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Official title
The Prognostic Value of the Degree of Pathological Response at One Cycle of Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinon-a Prospective Observational Study
Overview
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.
Primary outcome measures
- Progress-free survival (PFS) [Time frame: 3 years]
Secondary outcome measures (4)
- Overall Survival (OS) [Time frame: 3 years]
- Distant metastasis-free survival (DMFS) [Time frame: 3 years]
- Pathological complete response (pCR) rate [Time frame: At the end of Cycle 1 (each cycle is 21 days).]
- Infiltrating Immune cell density [Time frame: At the end of Cycle 1 (each cycle is 21 days).]
Eligibility criteria
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.
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
- Jingao Li — Nanchang
Identifiers
NCT: NCT06182657 · NPC-pCR