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

NCT ID: NCT06182657

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma Pathologic Complete Response Tumor Microenvironment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jingao Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangxi Provincial Cancer Hospital

Locations

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Jingao Li

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingao Li, PhD

Role: CONTACT

8613970866296

Tianzhu Lu, PhD

Role: CONTACT

Facility Contacts

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Tianzhu Lu

Role: primary

8615270186250

Other Identifiers

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NPC-pCR

Identifier Type: -

Identifier Source: org_study_id

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