Therapeutic Study of 177Lu-CTR-FAPI in Advanced Metastatic Digestive Malignancies (NCT07014254) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Therapeutic Study of 177Lu-CTR-FAPI in Advanced Metastatic Digestive Malignancies
China20 participantsStarted 2025-06-20
Plain-language summary
This was a single-centre, single-arm, non-blinded, prospective study using 20 patients with advanced metastatic GI malignancies recruited to treat patients with advanced metastatic GI malignancies with 177Lu-CTR-FAPI to assess the safety of 177Lu-CTR-FAPI in advanced metastatic GI malignancies; this included radiation therapy dosimetry and initial treatment Determination of Effectiveness
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Creatinine clearance ≥ 50 ml/min (calculated according to the Cockcroft-Gault formula) or serum creatinine ≤ 150 μmol/L;
✓. Urine protein \<2+; if urine protein ≥2+, then 24-hour urine protein quantification must show \<2 g of protein;
✕. Combination of other malignancies (except non-melanoma skin cancer or radical tumours without recurrence within 5 years);
✕. Presence of central nervous system metastases or carcinomatous meningitis;
✕. Uncontrolled cancer pain (requiring long-term high-dose opioids) or cachexia (≥20% weight loss in 6 months);
✕. Diabetes mellitus (fasting blood glucose \> 2 x ULN) that is not well controlled with optimal medical supportive therapy;
✕. Accompanied by poorly controlled plasmapheresis, including pleural fluid, ascites, and pericardial effusion; controlled with treatment and stable (asymptomatic, not requiring interventional therapy, and stable on imaging) for ≥2 weeks may be included;
✕. Severe urinary incontinence, hydronephrosis, severe voiding dysfunction or the need for an indwelling urinary catheter for any reason;
✕. Subjects with uncontrolled cardiac clinical symptoms or disease, including but not limited to: i) NYHA class 2 or higher heart failure; ii) unstable angina; iii) myocardial infarction within 1 year prior to enrolment; iv) left ventricular ejection fraction (LVEF) \<50%; v) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
✕. Co-occurring active hepatitis B (HBV-DNA testing is required for HBsAg-positive individuals with HBV DNA ≥500 IU/mL or 2500 copies/mL), and hepatitis C (HCV-Ab-positive and above the lower limit of detection of the analytical method);