Thyroid Cancer
Conditions
Interventions
Lenvatinib followed by iodine-131 treatment.:Lenvatinib followed by iodine-131 treatment.
Conventional Iodine-131 Therapy:Iodine-131 Therapy
Sponsors
The Second Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: If either criterion (3) or (4) is met, all other criteria must be satisfied simultaneously. (1) Voluntarily sign an informed consent form, understand the nature, purpose, and procedures of this trial and be able to complete the trial according to the protocol; (2) Age =18 years (as of the day of signing the informed consent form), gender not limited; (3) Locally advanced thyroid cancer, defined as follows: i. Extensive disease with multi-organ involvement, unresectable thyroid cancer; ii. Thyroidectomy did not achieve R0/R1 resection, thyroid cancer and/or locoregional metastatic lymph nodes invade at least one structure (trachea, esophagus, larynx, prevertebral fascia, brachial plexus) or encase at least one blood vessel (common carotid artery, mediastinal vessels); iii. After the first postoperative iodine-131 treatment, RAI scan or other imaging still shows highly suspicious and assessable lesions. (4) A clear history, confirmed metastatic differentiated thyroid cancer patients by imaging or histopathology (with lung metastasis or bone metastasis, etc.); (5) Postoperative patients with thyroid cancer that has iodine uptake function. (6) According to RECISTv1.1, at least one measurable lesion at baseline (CT, MRI, FDG-PET/CT, FDG-PET/MRI, etc.); (7) ECOG score 0-1, expected survival time more than 24 weeks; (8) Adequate organ and bone marrow function (subjects who have used any cells, growth factors, blood transfusions within 2 weeks before the first dose should be excluded), defined as follows: ? Hematology: HB =90g/L, ANC =1.5×10^9/L, PLT =80×10^9/L; ? Blood biochemistry: TBIL <1.5 times the upper limit of normal (ULN), ALT and AST <2.5×ULN, liver metastasis patients or liver cancer patients should be =5×ULN; ? Creatinine clearance (Ccr) =60ml/min (Ccr=(140-age)×weight(kg)/[72×serum creatinine value(mg/dl)], women multiply the result by 0.85); ? Routine urine: urinary protein <2+; ? Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), and Activated Partial Thromboplastin Time (APTT) =1.5×ULN; ? Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = lower limit of normal (50%). (9) Female subjects of childbearing age must have a negative serum pregnancy test result when entering this study (tested within 1 week before the first dose); female subjects of childbearing age or male subjects with partners of childbearing age are willing to use appropriate and effective contraceptive measures such as abstinence and double barrier methods (e.g., condoms plus diaphragm), oral contraceptives, intrauterine devices, etc., during the study period and for 6 months after the last dose, and should not donate eggs or sperm.
Exclusion criteria
Exclusion criteria: (1) History of other malignant tumors within the past 3 years, except for cured basal cell carcinoma of the skin and in situ cervical cancer; (2) Known positive pregnancy test, lactating, and other contraindications for iodine-131 treatment; (3) It is estimated that there will be no benefit from the next iodine-131 treatment; (4) Patients with hypertension that cannot be well controlled with two antihypertensive drugs (systolic blood pressure >150mmHg, diastolic blood pressure >100mmHg); (5) Significant cardiovascular and cerebrovascular damage, including but not limited to New York Heart Association (NYHA) class =II congestive heart failure or coronary heart disease, with a history of uncontrollable unstable angina, myocardial infarction, or ischemic cardiomyopathy, and a history of stroke within 6 months before screening; (6) Sinus bradycardia of grade 1 or above (CTCAE 5.0), second-degree or higher atrioventricular block, or sinus arrest (except for those with a pacemaker); (7) Arrhythmias (including QTc =470ms), requiring concurrent use of drugs known to prolong the QTc interval, including antiarrhythmic therapy; (8) Active or uncontrollable severe infection (infection =grade 2 by CTC AE); (9) Multiple factors affecting oral medication and absorption (such as inability to swallow, nausea and vomiting, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction), assessed as severely affecting the oral effect of medication; (10) Patients with a tendency to bleed (such as active peptic ulcer disease) or those treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar substances; (11) Imaging shows that the tumor has severely invaded important blood vessels, or the investigator judges that the tumor is very likely to invade important blood vessels during the subsequent study period, causing fatal major bleeding; (12) Plans to use traditional Chinese medicine for antitumor treatment at the same time; (13) Presence of long-term unhealed wounds or fractures; (14) Arterial or venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; (15) History of substance abuse with psychotropic drugs that cannot be quit, or history of mental disorders; (16) The investigator believes there are conditions that may harm the subject or cause the subject to be unable to meet or perform the requirements of the study, or the investigator considers other situations unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Progression-Free Survival (PFS);Time to Response (TTR);Biochemical Response Rate (BRR); | — |
Countries
China
Contacts
Public ContactYuan Peng
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed