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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

The Prognostic Value of the Degree of Pathological Response at One Cycle of Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinon-a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182657
• Other study ID #: NPC-pCR
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma

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).