Unresectable Locally Advanced/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Interventions
Group A:[68Ga]-R12961 Imaging
Group B: [177Lu]-R12961 Imaging
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent must be signed prior to performing any study procedures. 2. Male or female study participants aged >= 18 years. 3. Histologically or cytologically confirmed unresectable locally advanced/metastatic HNSCC. 4. At least one tumor lesion with a maximum diameter of >= 2 cm confirmed by standard imaging (contrast-enhanced CT or MRI) within 60 days prior to administration of 68Ga-R12961 or ¹77Lu-R12961. 5. ECOG performance status score of 0 to 2. 6. Estimated life expectancy > 3 months. 7. Adequate organ function, defined as: Absolute neutrophil count (ANC) >= 1.5×10?/L, platelet count >= 100×10?/L, hemoglobin >= 85 g/L; Total bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 × ULN (<= 5 × ULN in the presence of liver metastases); Serum creatinine (SCr) <= 1.5 × ULN. 8. For study participants of childbearing potential: the participant and/or their partner must use an acceptable, highly effective barrier contraceptive method during the study period and for at least 90 days after administration of 68Ga-R12961 or ¹77Lu-R12961, as deemed acceptable by the investigator.
Exclusion criteria
Exclusion criteria: 1. Received any investigational medicinal product or therapy targeting the same target within 2 months prior to the scheduled imaging date. 2. Participation in any other clinical trial or receipt of other investigational medicinal products (excluding observational trials). 3. Administration of any radiopharmaceutical within 10 half-lives of the corresponding radionuclide prior to administration of 68Ga-R12961 or ¹77Lu-R12961. 4. Received radiation therapy within 14 days prior to administration of 68Ga-R12961 or ¹77Lu-R12961. 5. Underwent surgery within 21 days prior to administration of 68Ga-R12961 or ¹77Lu-R12961, or planned surgery during the study period. 6. Presence of symptomatic brain metastases, or ongoing high-dose corticosteroid therapy to maintain integrity of central nervous system function. 7. Presence of other active malignant diseases that may interfere with disease assessment. Study participants with a history of previous malignancy may be enrolled if they have been in complete remission with no evidence of recurrence for at least 3 years prior to administration of 68Ga-R12961 or ¹77Lu-R12961. 8. Presence of uncontrolled comorbid medical conditions, including but not limited to severe infections requiring hospitalization or prolonged antibiotic therapy. 9. Severe cardiovascular disease, such as chronic heart failure of NYHA Class III–IV, uncontrolled hypertension, malignant arrhythmia, unstable angina pectoris, history of coronary artery bypass grafting (CABG) or myocardial infarction (MI) within 6 months prior to study screening. 10. Known active hepatitis B or hepatitis C infection. 11. Study participants who are unwilling or unable to undergo PET/CT or SPECT/CT scanning during the study period for any reason. 12. Presence of any uncontrolled significant medical, psychiatric, or surgical disorder or laboratory abnormality that, in the investigator’s judgment, may pose a risk to the safety of study participants or interfere with study participation. 13. Known or suspected hypersensitivity to 68Ga-R12961 or ¹77Lu-R12961 or any of their components. 14. Pregnant or lactating women. 15. Presence of other serious medical conditions that, in the investigator’s judgment, render the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biodistribution;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging Quality Analysis;Dosimetry Analysis; | — |
Countries
China
Contacts
Public ContactRui Gao
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed