Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: Lutetium177 FAPi therapy infusion: Intravenous infusion of 150-200 mCi of Lu177 FAPi diluted in 100ml normal saline over 30 minutes. After FAPi therapy infusion is over, Normal Saline i
Sponsors
Tata Research and Administrative Council(TRAC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven metastatic or locally advanced Gastric carcinoma patients progressed on 2 or more than 2 lines of standard systemic therapy & having positive Gallium68 FAPi PET or CT scan Criteria for positivity of Gallium68 FAPi PET or CT- Any lesion with tumor-to-liver SUV ratio above or equal to 3 on screening 68Ga FAPi 2286 PET or CT will be considered FAPi positive 2. Age more than or equal to 18 3. ECOG less than or equal 2 4. Normal haematological function (Hb more than 8, PLT more than 80000, ANC more than 1500) 5. Optimal renal function (Calculated Creatinine clearance more than 30 ml per min) 6. Optimal liver function (Total bilirubin less than 1.5 times institutional upper limit of normal. 7.AST and ALT less than or equal to 2.5 times institutional upper limit of normal) 8. Serum Albumin more than 30 g per liters
Exclusion criteria
Exclusion criteria: 1. Past history of second malignancy 2. Participants who are receiving any other investigational agents 3. Patients who have received any cancer-directed therapy within 3 weeks of screening for this study 4. Prior radiopharmaceutical therapy 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study 6. Uncontrolled intercurrent illness including or psychiatric illness/social situations that would limit compliance with study requirements 7. Pregnant women and breastfeeding women 8. Patient?s refusal to give informed consent and participate in the study 9. Clinically significant and/or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association less than Class 2), uncontrolled hypertension, clinically significant arrhythmia 10. Acute coronary syndrome or acute myocardial infarction less than or equal to 6 months prior to administration of study intervention 11. Active HIV or HBV infections 12. Non-study-related minor surgical procedure less than 5 days, or major surgical procedure less than 21 days, prior to the administration of study intervention in all cases, the participant must be sufficiently recovered and stable before treatment administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine disease control rate in metastatic gastric carcinoma patients progressed on 2 or more than 2 lines of standard treatment receiving Lu177 FAPi therapy.Timepoint: 6-8 weeks after each therapy session | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety profile expressed in terms of incidence of grade 3 and above toxicity or proportion of patients developing grade 3 and above in metastatic gastric carcinoma patients receiving Lutetium 177 FAPi therapy.Timepoint: 48 hrs, 72 to 96 hrs and 2 week, 4 weeks and at 6 weeks after drug administratioin;To assess quality of life in these patients using EORTC questionnaires QLQ C30 & QLQ STO22Timepoint: 4 weeks and 8 weeks after each therapy session | — |
Countries
India
Contacts
Public ContactDR Indraja Devidas Dev
ADVANCED CENTRE FOR TREATMENT RESEARCH AND EDUCATION IN CANCER TATA MEMORIAL CENTRE
Outcome results
None listed