Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort evaluates whether 68Ga-FAPI-LM3 PET/CT improves NPC staging accuracy and whether 68Ga-PD-L1 PET/CT can predict early response to neoadjuvant immunotherapy. It analyzes changes in PET uptake parameters before and after treatment and compares treatment outcomes and survival by residual uptake and immunotherapy use. The study will report sensitivity and specificity for staging and response prediction for each tracer. Eligibility includes adults 18-70 with histologically confirmed non-keratinizing NPC, stage I–IVA, ECOG 0–1, and no prior anti-tumor therapy. No interventional treatment is specified within the report; observational data will be collected across multiple institutions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Any sex; age 18-70 years.
2. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (World Health Organization (WHO) type II or III).
3. Clinical stage I-IVA (American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition) with no evidence of distant metastasis.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
5. No prior anti-tumor treatment for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, immunotherapy, or biologic therapy.
6. No contraindications to radiotherapy or chemotherapy.
7. Adequate major organ function as defined below:

   7.1 Hematology: white blood cell (WBC) ≥ 4.0 × 10\^9/L, absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L (no blood transfusion or blood products within 14 days and no use of granulocyte colony-stimulating factor (G-CSF) or other hematopoietic growth factors to correct counts);

   7.2 Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); blood urea nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min calculated by the Cockcroft-Gault formula.
8. Participant voluntarily agrees to join the study, signs informed consent, has good compliance, and is able to attend follow-up.

Exclusion Criteria:

1. Pathological type of keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. History of or concurrent other active (unresolved) malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial bladder cancer.
3. Currently participating in another clinical trial.
4. Pregnant or breastfeeding women.
5. Uncontrolled cardiovascular disease, including ≥ Grade II myocardial ischemia or myocardial infarction, uncontrolled cardiac arrhythmias (including corrected QT (QTc) interval ≥ 470 ms); heart failure New York Heart Association (NYHA) class III-IV, or left ventricular ejection fraction (LVEF) \< 50% on echocardiography; or myocardial infarction within the past year.
6. Other severe comorbidities such as uncontrolled hypertension, severe cerebrovascular disease, severe renal disease, uncontrolled diabetes mellitus, or other chronic wasting diseases.
7. History of substance or alcohol abuse, psychiatric illness, or lack of full or having limited civil capacity.
8. In the investigator's judgment, other familial or social factors that could force premature withdrawal from the study, or other conditions likely to affect participant safety or the collection of trial data.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, China Recruiting

Study contacts

• Study coordinator: Qin Lin, Doctor
• Email: linqin05@163.com
• Phone: +8613806000926

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.