Status:
COMPLETED
68Ga-FAPI-46 PET/CT for the Prediction of Clinical Response to Neoadjuvant Therapy in Nasopharyngeal Carcinoma Patients
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Nasopharyngeal Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
The goal of this clinical trial is to learn about the prediction of clinical response to neoadjuvant therapy in nasopharyngeal carcinoma patients via 68Ga-FAPI-46 PET/CT. The main question it aims to ...
Eligibility Criteria
Inclusion
- Individuals of either gender, aged between 18 and 70 years;
- Histopathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III);
- Clinical stage III-IVa according to the AJCC/UICC 8th edition criteria, with no evidence of distant metastasis;
- ECOG performance status score of 0 or 1;
- No prior anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy, or biological therapy, for nasopharyngeal carcinoma; ⑹ No contraindications to radiotherapy or chemotherapy; ⑺ Adequate major organ function as defined by the following criteria:
- Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (without blood transfusion, blood products, or hematopoietic growth factors such as G-CSF within the past 14 days);
- Biochemical criteria: ALT and AST ≤ 2.5 × upper limit of normal (ULN); BUN and CRE ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula); ⑻ Willing participation in the study, with signed informed consent, good compliance, and willingness to cooperate with follow-up procedures.
Exclusion
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- The pathological type was keratinizing squamous cell carcinoma or basal-like squamous cell carcinoma.
- Patients with a history of prior or concurrent malignant tumors that have not been cured, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer;
- Participation in other clinical trials;
- Pregnant or lactating women;
- Uncontrolled cardiovascular diseases, including myocardial ischemia or myocardial infarction of Grade II or higher, poorly controlled arrhythmias (including a QTc interval ≥ 470 ms); patients with NYHA Class III-IV heart failure or left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiography; myocardial infarction within the past year;
- Other severe comorbidities such as uncontrolled hypertension, severe cerebrovascular disease, severe renal disease, uncontrolled diabetes mellitus, and other chronic debilitating conditions;
- A history of substance abuse or alcohol dependence, psychiatric disorders, or individuals with no or limited civil capacity;
- According to the investigator's judgment, the subject has familial or social factors that may lead to premature termination of participation in the study, potentially affecting the subject's safety or the integrity of the study data;
- Patients with known hypersensitivity to ethanol.
Key Trial Info
Start Date :
January 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 10 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT07139054
Start Date
January 31 2024
End Date
August 10 2025
Last Update
August 24 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, China