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Enrolling By Invitation
NCT07822347
Research on NI-FAPI-04 for the Treatment of Hypoxic and Fibroblast Activation Protein Related Tumors
Conditions: Tumor
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 20
Sponsor: Peking Union Medical College Hospital
Location: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing Beijing Municipality
Summary
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. This study will lay the foundation for the further application of NI-FAPI-04 in tumor therapy and achieve the integration of molecular targeted probes for diagnosis, treatment, and efficacy monitoring.
Eligibility Criteria
Inclusion Criteria:
* Age between 18-80 years old
* Obtain pathological results through surgery or biopsy
* Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria)
* Expected survival time greater than 6 months
* Baseline \[68Ga\] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions
* Informed consent and the ability to accept follow-up
* Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L
* Liver function: AST/ALT ≤ 3 × ULN, or subjects with liver metastasis\3.0 g/dL; Total bilirubin ≤ 1.5 × ULN
* Renal function: creatinine clearance rate ≥ 50 mL/min
* Coagulation function: INR ≤ 1.5 (for patients who have not received warfarin treatment); Prothrombin time (PTT)\
Source: ClinicalTrials.gov (NCT07822347). StuddyBuddy aggregates publicly available trial information.