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

Jiangxi Provincial Cancer Hospital

Status: Enrolling

Conditions: Tumor Microenvironment; Nasopharyngeal Carcinoma; Pathologic Complete Response

Study type: Observational

Funder types: Other

Identifiers

NCT06182657

NPC-pCR

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ability to sign informed consent
2. Age > 18 years at time of study entry
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
4. Histological confirmation of NPC (regardless if EBER positive or negative)
5. Locally advanced NPC, UICC stage III-IVa
6. 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

1. 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
2. Distant metastases
3. Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC.
4. History of another primary malignancy
5. Female patients who are pregnant
6. Known allergy or hypersensitivity to any drugs
7. 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.