Advanced malignant solid tumours confirmed by histological or cytological examination
Conditions
Interventions
Experimental Group:Treatment with 177Lu-FAPI injection is administered using a dose-escalation protocol
the actual dose may vary by up to ±10% of the planned dose and is infused via an infusion pump at a rate of 60 ml/h. To prevent gastrointestinal reactions, 3 mg of granisetron is administered intraven
Sponsors
The Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical trial, understand the study procedures, and be capable of signing the written informed consent form. 2. Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no available standard treatment options, or decline standard treatment. 3. Patients confirmed to have positive FAP expression via screening with 68Ga-FAPI PET/CT imaging. 4. Aged between 18 and 75 years, with good general physical condition to tolerate the study treatment and relevant examinations, and an expected survival of at least 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 6. The tumor contains measurable lesions; at least one lesion with measurable single diameter in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1). 7. Laboratory hematological criteria: white blood cell count >= 3.0 × 10?/L, absolute neutrophil count >= 1.5 × 10?/L, platelet count >= 80 × 10?/L, and hemoglobin >= 90 g/L. 8. Hepatic and renal function shall meet the following limits: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50 mL/min. 9. For women of childbearing potential: a serum pregnancy test performed within 72 hours prior to the first study administration must be negative; subjects shall not be breastfeeding, and must agree to use highly effective contraceptive methods throughout the trial period and for 7 months after the end of treatment. Male subjects shall agree to adopt highly effective contraception during the study and for 4 months after treatment completion, or have undergone surgical sterilization.
Exclusion criteria
Exclusion criteria: 1.Subjects with severe cardiac diseases, including heart failure (New York Heart Association [NYHA] Class IV), unstable angina, or myocardial infarction within the past 6 months. Recent electrocardiogram and echocardiography shall be provided for cardiac function assessment. 2.Subjects with severe respiratory disorders, such as severe chronic obstructive pulmonary disease (COPD) with severely impaired pulmonary function (forced expiratory volume in one second < 30% of predicted value) or severe interstitial lung disease. Pulmonary function tests shall be conducted to confirm respiratory status. 3.Subjects with uncontrolled active infections including sepsis and severe pneumonia. Recent routine blood tests, inflammatory biomarkers and etiological examination results are required for verification. 4.Subjects with psychiatric disorders or cognitive impairment who are unable to understand or comply with study requirements. 5.Pregnant or breastfeeding women, confirmed via serum HCG test, urine pregnancy test or other relevant examinations. 6.Subjects with a known history of allergy to study drugs or radioactive substances. Detailed allergy history and associated symptoms shall be collected. 7.Subjects with active severe autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis; relevant laboratory test results shall be provided. 8.Participation in any other clinical trial within the previous 4 weeks, to avoid drug-drug interactions and confounding of study outcomes. 9.Severe hematopoietic dysfunction (e.g., aplastic anemia) confirmed by blood routine and bone marrow examination; subjects with severe bleeding tendency or receiving anticoagulant therapy that cannot be temporarily discontinued. Coagulation function parameters will be evaluated for screening. 10.Severe hepatic or renal impairment including decompensated liver cirrhosis and uremia, defined as liver function parameters exceeding 5 times the upper limit of normal (ULN) or serum creatinine above 3 times ULN. 11. Receipt of systemic anti-cancer therapies (radiotherapy, chemotherapy, immunotherapy, biotherapy, etc.) within 4 weeks prior to the first study dose; or planned use of cytotoxic chemotherapy, anti-tumor immunotherapy, radiopharmaceutical ligand therapy or other similar anti-neoplastic agents during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Incidence of Adverse Events by Grade;Dose-limiting toxicity (DLT);Radiometric parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Progression-Free Survival (mPFS);Outcome Disease Control Rate (DCR);Outcome Objective Response Rate (ORR);Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactWang Xuemei
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed