The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2023
CompletedFirst Posted
Study publicly available on registry
December 27, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
February 8, 2024
July 1, 2023
3.5 years
July 20, 2023
February 7, 2024
Conditions
Outcome Measures
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.
3 years
Secondary Outcomes (4)
Overall Survival (OS)
3 years
Distant metastasis-free survival (DMFS)
3 years
Pathological complete response (pCR) rate
At the end of Cycle 1 (each cycle is 21 days).
Infiltrating Immune cell density
At the end of Cycle 1 (each cycle is 21 days).
Eligibility Criteria
Patients with biopsy proven stage III-IVA NPC (according to the 8th edition of Union for International Cancer Control stage classification).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jingao Li
Nanchang, Jiangxi, 330029, China
Biospecimen
biopsy tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingao Li, PhD
Jiangxi Provincial Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2023
First Posted
December 27, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2029
Last Updated
February 8, 2024
Record last verified: 2023-07