ClinicalTrials.gg
RecruitingNCT06182657Updated Feb 8, 2024

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

An observational study in Nasopharyngeal Carcinoma, Pathologic Complete Response and Tumor Microenvironment, sponsored by Jiangxi Provincial Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by Jiangxi Provincial Cancer Hospital · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasopharyngeal Carcinoma
  • Pathologic Complete Response
  • Tumor Microenvironment
03

In context

Nasopharyngeal Carcinoma

683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.

This study's planned enrollment of 300 is close to the median of 300 across 118 observational studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Jiangxi Provincial Cancer Hospital is the lead sponsor of 34 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to sign
  2. Age > 18 years at time of study entry
  3. (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

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
  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
  5. Female patients who are pregnant
  6. Known allergy or 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival (OS)

    OS is defined as the time from treatment to death, regardless of disease recurrence.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

  3. Pathological complete response (pCR) rate

    pCR is defined as the absence of residual invasive.

    Time frame: At the end of Cycle 1 (each cycle is 21 days).

  4. Infiltrating Immune cell density

    CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure

    Time frame: At the end of Cycle 1 (each cycle is 21 days).

07

Study locations

1 of 1 sites recruiting
  • Jingao Li
    Nanchang, Jiangxi 330029, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06182657
Lead sponsor
Jiangxi Provincial Cancer Hospital
Responsible party
Sponsor
First posted
Dec 27, 2023
Start date
Jan 1, 2024
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Feb 8, 2024

Study contacts

Jingao Li, PhD
Contact
lijingao@hotmail.com
8613970866296
Tianzhu Lu, PhD
Contact
lutianzhu2008@163.com
Jingao Li, PhD
principal investigator · Jiangxi Provincial Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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