Metastatic colon cancer. Malignant neoplasm of colon
Conditions
Interventions
Intervention 1: Intervention group: Patients treated with the radiopharmaceutical lutetium FAPI , IV infusion of lutetium lu-177 FAPI (200 mCi) every 45 days for 4 doses. Intervention 2: Control group
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years. Histopathologically confirmed metastatic colorectal adenocarcinoma. Proficient Mismatch Repair (pMMR) status Documented disease progression or intolerance to all of the following standard therapies: 1.A fluoropyrimidine (e.g., capecitabine or 5-fluorouracil [5FU]) 2.Irinotecan 3.Oxaliplatin 4.Bevacizumab 5.For patients with RAS and BRAF wild-type tumors: prior treatment with at least one line of an anti-EGFR therapy (e.g., Panitumumab or Cetuximab) is required. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. Adequate bone marrow, hepatic, and renal function prior to study initiation, as defined by: Hemoglobin (HGB) = 8 g/dL , Absolute Neutrophil Count (ANC) = 1000/µL , Platelet Count (PLT) = 75,000/µL , Total Bilirubin = 2.0 mg/dL (or upper limit of normal [ULN]) , Serum Transaminases (AST/ALT) = 100 U/L (or = 2.5 x ULN in presence of liver metastases) , Serum Creatinine (Cr) = 1.5 mg/dL (or ULN) Ability to provide written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: Candidates for local therapeutic intervention (e.g., surgery or radiotherapy) with curative intent for metastatic lesions. Voluntary Withdrawal: Unwillingness to continue participation in the study at any point. Severe Organ Dysfunction: Evidence of severe hepatic, renal, or bone marrow insufficiency not meeting the minimum inclusion criteria Contraindication to Radiotherapy: A history of severe hypersensitivity reactions to radiopharmaceuticals or any of their components. Pregnancy and Lactation: Current pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor radiologic response (RECIST). Timepoint: Before intervention and then every 2 monthes. Method of measurement: CT scan.;CEA. Timepoint: Before intervention and then monthly. Method of measurement: Measurement of serum tumor marker levels.;6 months Progression free survival. Timepoint: 6 months after intervention. Method of measurement: Disease progression criteria based on NCCN criteria. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Haji Aghajani
Tehran University of Medical Sciences
Outcome results
None listed