Nasopharyngeal Carcinoma, Pathologic Complete Response, Tumor Microenvironment
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress-free survival (PFS) | 3 years | PFS is defined as the time from treatment to date of first documentation of progression or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3 years | OS is defined as the time from treatment to death, regardless of disease recurrence. |
| Distant metastasis-free survival (DMFS) | 3 years | DMFS is defined as the time from diagnosis to the date of distant metastasis or when censored at the latest date. |
| Pathological complete response (pCR) rate | At the end of Cycle 1 (each cycle is 21 days). | pCR is defined as the absence of residual invasive. |
| Infiltrating Immune cell density | At the end of Cycle 1 (each cycle is 21 days). | CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure |
Countries
China
Contacts
Primary ContactJingao Li, PhD
Backup ContactTianzhu Lu, PhD
Outcome results
None listed