Evaluating the impact of chemotherapy response in nasopharyngeal carcinoma
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 is trying to see if how well patients with advanced nasopharyngeal carcinoma respond to the first round of chemotherapy can give clues about their future health and immune system changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangxi Provincial Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT06182657 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prognostic significance of pathological remission following one cycle of induction chemotherapy in patients with locally advanced nasopharyngeal carcinoma. It aims to assess changes in the immune microenvironment, including the infiltration of immune cells and the presence of tertiary lymphoid structures after treatment. By analyzing these factors, the study seeks to provide insights into the relationship between chemotherapy response and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with histologically confirmed locally advanced nasopharyngeal carcinoma.
Not a fit: Patients with distant metastases or those who have received prior systemic anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are likely to benefit from specific treatment strategies based on their chemotherapy response.
How similar studies have performed: While there have been studies examining chemotherapy responses in various cancers, the specific focus on the immune microenvironment in nasopharyngeal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanchang, Jiangxi
- Jingao Li — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Principal investigator: Jingao Li, PhD — Jiangxi Provincial Cancer Hospital
- Study coordinator: Jingao Li, PhD
- Email: lijingao@hotmail.com
- Phone: 8613970866296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.