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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06182657
Other study ID # NPC-pCR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date June 30, 2029

Study information

Verified date July 2023
Source Jiangxi Provincial Cancer Hospital
Contact Jingao Li, PhD
Phone 8613970866296
Email lijingao@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2029
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Jingao Li Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Survival (OS) OS is defined as the time from treatment to death, regardless of disease recurrence. 3 years
Secondary 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. 3 years
Secondary Pathological complete response (pCR) rate pCR is defined as the absence of residual invasive. At the end of Cycle 1 (each cycle is 21 days).
Secondary Infiltrating Immune cell density CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure At the end of Cycle 1 (each cycle is 21 days).
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