The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJiangxi Provincial Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with biopsy proven stage III-IVA NPC (according to the 8th edition of Union for International Cancer Control stage classification).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
3 yearsSecondary outcomes
1
Overall Survival (OS)
OS is defined as the time from treatment to death, regardless of disease recurrence.
Time frame
3 years2
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.
Time frame
3 years3
Pathological complete response (pCR) rate
pCR is defined as the absence of residual invasive.
Time frame
At the end of Cycle 1 (each cycle is 21 days).4
Infiltrating Immune cell density
CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure
Time frame
At the end of Cycle 1 (each cycle is 21 days).Sponsors and contacts
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Source ClinicalTrials.gov