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NCT Number: NCT06182657

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Disease Attributes Disease Progression Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Tumor Microenvironment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jingao Li

Nanchang, Jiangxi, 330029, China

Location status: Recruiting

Location contact

Tianzhu Lu

CONTACT

[email protected]

8615270186250

Xiaochang Gong, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to sign informed consent
  • Age > 18 years at time of study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
  • Histological confirmation of NPC (regardless if EBER positive or negative)
  • Locally advanced NPC, UICC stage III-IVa
  • 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

  • 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
  • Distant metastases
  • Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC.
  • History of another primary malignancy
  • Female patients who are pregnant
  • Known allergy or hypersensitivity to any drugs
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 3 years

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

  2. 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. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jingao Li, PhD

CONTACT

[email protected]

8613970866296

Tianzhu Lu, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Dec 27, 2023
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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