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

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Pathologic Complete Response; Tumor Microenvironment

• Registration Number: NCT06182657
• Lead Sponsor: Jiangxi Provincial Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-12-25
• Study First Posted: 2023-12-27
• Study Start: 2024-01-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2027-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.

Trial Locations

Locations (1)

Jingao Li; 🇨🇳 Nanchang, Jiangxi, China