Thyroid cancer
Conditions
Interventions
Intervention group:177Lu-LNC1004 injection treatment
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Able to understand and voluntarily sign a written informed consent form (ICF); 2) Able to understand the requirements of the trial, willing and able to comply with the trial and follow-up procedures; 3) Age 18 and above, male or female; 4) Patients with RAIR-DTC who have been histologically or cytologically confirmed, progressed after treatment with TKIs (such as sorafenib, lenvatinib, anlotinib, pratinib and larotrectinib, etc.) or who have refused standard therapy, and are currently receiving treatment in the Department of Nuclear Medicine, Peking Union Medical College Hospital; 5) Performance status score of 0-2 according to Eastern Cancer Cooperative (ECOG) criteria; 6) at least one measurable target lesion according to RECIST 1.1 criteria; 7) Patients should be treated with thyroid-stimulating hormone (TSH) suppression, and the serum TSH level should be less than 0.5 mIU/mL; 8) Expected survival> 6 months; 9) FAP positive as confirmed by FAPI PET/CT scan; 10) Organ function requirements before the first dose are as follows: bone marrow function: hemoglobin > = 100 g/L, neutrophil count > = 1.5×10^9/L, platelet count > = 100×10^9/L; Liver function: albumin > = 3.0 g/dL; Total bilirubin = 60 mL/min according to Cockcroft-Gault formula; Coagulation function: INR < = 1.5 (patients not treated with warfarin); Prothrombin time (PTT) < 2× ULN; 11) Toxicity to Grade 0 or 1 (CTCAE V5.0) from prior anti-tumor therapy (a. Hair loss; b. Pigmentation; c. Long-term toxicity caused by radiotherapy, except for those judged by the investigator to be irreversible); 12) Agree to take radiation protection measures as prescribed by the doctor during the test.
Exclusion criteria
Exclusion criteria: 1) Those who have brain metastases at the time of screening, except for those who have asymptomatic brain metastases that can be included after being evaluated by the investigator or who have received previous brain metastasis treatment and the lesions have been stable for more than 4 weeks confirmed by imaging; 2) History of other known malignant tumors within 50%; 7) Received blood transfusion therapy within 4 weeks prior to screening to make the subject meet the enrollment criteria; 8) Participation in investigational drug or device clinical trials within 4 weeks prior to the first dose; 9) Those who have had hypersensitivity reactions or delayed allergic reactions to some components of 177Lu-LNC1004 injection or similar drugs in the past; 10) Those who have undergone major surgery within 4 weeks before the first dose and have not fully recovered and plan to undergo major surgery during the study; 11) Those with severe cardiovascular and cerebrovascular diseases, including but not limited to the following: those who have undergone coronary angioplasty, stent implantation, coronary artery bypass grafting and defibrillation device implantation due to arrhythmia within 6 months; Presence of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II.-III. atrioventricular block, etc.; Abnormal ECG examination during the screening period and judged to be clinically significant by the investigator, including those with QTcF > 470 ms; New York College of Cardiology (NYHA) grade >= grade 3; Presence of aortic dissection, stroke or other cardiovascular and cerebrovascular events of NCI CTCAE (V5.0) grade 3 or above within 6 months; 12) Active infection requiring intravenous antibiotic treatment with bacterial, fungal or viral infection and any other uncontrolled active infection such as active tuberculosis within 4 weeks prior to the first dose; 13) Known history of human immunodeficiency virus (HIV) infection or positive HIV virus test, or active hepatitis. Patients with hepatitis B, if hepatitis B surface antigen positive, are tested for HBV DNA, HBV DNA < 1×10^4 copies/mL or < 2000 IU/mL, they may be enrolled and may receive concomitant antiviral therapy during study treatment, as judged by clinical judgment; Patients with hepatitis C are tested for HCV RNA if they are positive for hepatitis C virus antibodies, and can be enrolled if they test negative for HCV RNA. 14) Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past; 15) Those who need treatment or have uncontrollable pleural effusion or ascites as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Response (DOR);Progression-free survival (PFS);Adverse Events (AEs);Serious Adverse Events (SAEs);Treatment-Related Adverse Events (TRAEs); | — |
Countries
China
Contacts
Public ContactYansong Lin
Peking Union Medical College Hospital
Outcome results
None listed