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

February 7, 2024 updated by: Jiangxi Provincial Cancer Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jingao Li
        • Contact:
        • Sub-Investigator:
          • Xiaochang Gong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with biopsy proven stage III-IVA NPC (according to the 8th edition of Union for International Cancer Control stage classification).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival (PFS)
Time Frame: 3 years
PFS is defined as the time from treatment to date of first documentation of progression or death due to any cause.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 3 years
OS is defined as the time from treatment to death, regardless of disease recurrence.
3 years
Distant metastasis-free survival (DMFS)
Time Frame: 3 years
DMFS is defined as the time from diagnosis to the date of distant metastasis or when censored at the latest date.
3 years
Pathological complete response (pCR) rate
Time Frame: At the end of Cycle 1 (each cycle is 21 days).
pCR is defined as the absence of residual invasive.
At the end of Cycle 1 (each cycle is 21 days).
Infiltrating Immune cell density
Time Frame: At the end of Cycle 1 (each cycle is 21 days).
CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure
At the end of Cycle 1 (each cycle is 21 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi Provincial Cancer Hospital

Investigators

  • Principal Investigator: Jingao Li, PhD, Jiangxi Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

December 25, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-pCR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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