Status:
NOT_YET_RECRUITING
Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
Sun Yat-sen University
Peking University Shenzhen Hospital
Conditions:
Nasopharyngeal Carcinoma (NPC)
PET / CT
Eligibility:
All Genders
18-70 years
Brief Summary
This is an observational cohort study designed to (1) evaluate whether Gallium-68 (68Ga)-labeled fibroblast activation protein inhibitor ligand LM3 (68Ga-FAPI-LM3) positron emission tomography/compute...
Eligibility Criteria
Inclusion
- Any sex; age 18-70 years.
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (World Health Organization (WHO) type II or III).
- Clinical stage I-IVA (American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition) with no evidence of distant metastasis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- No prior anti-tumor treatment for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, immunotherapy, or biologic therapy.
- No contraindications to radiotherapy or chemotherapy.
- Adequate major organ function as defined below:
- 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);
- 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.
- Participant voluntarily agrees to join the study, signs informed consent, has good compliance, and is able to attend follow-up.
Exclusion
- Pathological type of keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- 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.
- Currently participating in another clinical trial.
- Pregnant or breastfeeding women.
- 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.
- Other severe comorbidities such as uncontrolled hypertension, severe cerebrovascular disease, severe renal disease, uncontrolled diabetes mellitus, or other chronic wasting diseases.
- History of substance or alcohol abuse, psychiatric illness, or lack of full or having limited civil capacity.
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2029
Estimated Enrollment :
732 Patients enrolled
Trial Details
Trial ID
NCT07137052
Start Date
September 30 2025
End Date
January 30 2029
Last Update
September 17 2025
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