Nasopharyngeal Carcinoma (NPC)NCT06763640

Prognostic Value of TIL in Nasopharyngeal Carcinoma

An observational study of Nasopharyngeal Carcinoma (NPC), run by Jiangxi Provincial Cancer Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Our center plans to conduct a prospective, multicenter, observational study aimed at observing the percentage of TIL infiltration calculated using deep learning methods based on digital pathological images, and analyzing its prognostic significance in nasopharyngeal carcinoma, in order to help guide personalized… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nasopharyngeal Carcinoma (NPC)
How many people: 216 participants
Where: 1 siteChina
Study dates: 1 Jan 2025to 31 Dec 2028
How long will I take part?: 2 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Jiangxi Cancer Hospital

Who may be able to join

Histopathology confirms nasopharyngeal carcinoma;
At the initial treatment, there was no evidence of distant metastasis, and the staging was II-III (AJCC 9th);
Age range of 18-70 years old, KPS ≥ 80 points;
Having good organ function; The following conditions must be met: Hematology: White blood cell count>3.0 × 109/L; Absolute neutrophil count (ANC)>1.5 × 109/L; Hb>90g/L； Platelets>100 × 109/L; Albumin ≥ 3g/dL Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase (ALP) ≤ 3 times ULN • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; • Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60mL/min.
Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures;
Willing to comply with arrangements during the research period and cannot participate in any other clinical studies related to drugs and medical devices;
Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies.
Sufficient tissue stored in wax blocks suitable for scientific research use.

Who cannot join

Merge with other malignant tumors
Individuals with a history of severe immediate hypersensitivity to any medication used in this study
No capacity for civil conduct or limited capacity for civil conduct;
Abuse of drugs or alcohol addiction, patients with physical or mental illnesses, and those deemed by the researchers to have a complete or thorough understanding of the possible complications of this study;
Other serious acute or chronic medical conditions (including immune-mediated colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illnesses (including dementia and epilepsy, recent, past year, or active suicidal ideation or behavior) that may increase the risks associated with the study protocol treatment, or may interfere with the interpretation of study results and (based on the researcher's judgment) make patients unsuitable for participation in this study, or laboratory test abnormalities;
Previously diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases;
Pregnant or lactating female patients, male or female patients who have fertility but are unwilling or unable to use contraception for at least one year throughout the study period and after the end of the treatment plan.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029

Other trials in China

About this study

Official title: Prognostic Value of Deep Learning-Derived Tumor-Infiltrating Lymphocyte Percentage in Nasopharyngeal Carcinoma: a Prospective Observational Study

Conditions: Nasopharyngeal Carcinoma (NPC)
Keywords: nasopharyngeal carcinoma, digital pathology images, deep learning, tumor-infiltrating lymphocytes, metastatic risk
Medical subject headings: Nasopharyngeal Carcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease Free Survival (DFS)
DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death
Measured: 3 Years

Secondary outcomes (4)

Overall Survival
Overall Survival was defined as the interval from the date of diagnosis to the date of death for any cause
Measured: 3 Years
Distant Metastasis-free Survival
DMFS was defined as the interval from the date of diagnosis to the data of distant metastases or censored at the date of last follow-up
Measured: 3 Years
Locoregional Recurrenc-free Survival
LRRFS was defined as the interval from the date of diagnosis to the data of locoregional recurrence or censored at the date of last follow-up
Measured: 3 Years
Objective Response Rate
Objective response rate is defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Measured: During induction chemotherapy (up to 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202531 Dec 2028

First posted8 Jan 2025
Study start1 Jan 2025 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 216 participants (estimated)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06763640
Sponsor's protocol ID: SKJP1320241975
Status last verified: Jan 2025
First submitted: 25 Dec 2024
Last updated: 9 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma

All Nasopharyngeal Carcinoma (NPC) trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prognostic Value of Deep Learning-Derived Tumor-Infiltrating Lymphocyte Percentage in Nasopharyngeal Carcinoma: a Prospective Observational Study
ClinicalTrials.gov ID: NCT06763640
Acronym / sponsor ID: SKJP1320241975
Conditions: Nasopharyngeal Carcinoma (NPC)
Keywords: nasopharyngeal carcinoma, digital pathology images, deep learning, tumor-infiltrating lymphocytes, metastatic risk
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 216 participants (estimated)
Lead sponsor: Jiangxi Provincial Cancer HospitalUniversity, hospital or other
Study start: 1 Jan 2025 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 8 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Years

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Jiangxi Cancer Hospital

Key inclusion criteria (8 listed)

Histopathology confirms nasopharyngeal carcinoma;
At the initial treatment, there was no evidence of distant metastasis, and the staging was II-III (AJCC 9th);
Age range of 18-70 years old, KPS ≥ 80 points;
Having good organ function; The following conditions must be met: Hematology: White blood cell count>3.0 × 109/L; Absolute neutrophil count (ANC)>1.5 × 109/L; Hb>90g/L； Platelets>100 × 109/L; Albumin ≥ 3g/dL Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase (ALP) ≤ 3 times ULN • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; • Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60mL/min.
Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures;

Key exclusion criteria (7 listed)

Merge with other malignant tumors
Individuals with a history of severe immediate hypersensitivity to any medication used in this study
No capacity for civil conduct or limited capacity for civil conduct;
Abuse of drugs or alcohol addiction, patients with physical or mental illnesses, and those deemed by the researchers to have a complete or thorough understanding of the possible complications of this study;
Other serious acute or chronic medical conditions (including immune-mediated colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illnesses (including dementia and epilepsy, recent, past year, or active suicidal ideation or behavior) that may increase the risks associated with the study protocol treatment, or may interfere with the interpretation of study results and (based on the researcher's judgment) make patients unsuitable for participation in this study, or laboratory test abnormalities;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Disease Free Survival (DFS)
Time frame: 3 Years
DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death

4 secondary outcomes

Overall Survival
Time frame: 3 Years
Distant Metastasis-free Survival
Time frame: 3 Years
Locoregional Recurrenc-free Survival
Time frame: 3 Years
Objective Response Rate
Time frame: During induction chemotherapy (up to 3 months)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.

Related trials for Nasopharyngeal Carcinoma (NPC)

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Nasopharyngeal Carcinoma (NPC), run by Jiangxi Provincial Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.