Thyroid Cancer
Conditions
Interventions
treatment group:Donafenib combined with 131I
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Participants must voluntarily enroll in this study, sign an informed consent form, and have good compliance; 2) Aged 18 years or older (inclusive of the boundary value), with no gender restrictions; 3) The subjects who were diagnosed with recurrent/metastatic Differentiated Thyroid Cancer (DTC) following thyroidectomy (total or near-total) based on imaging or clinical diagnosis; 4) Participants must not have previously received systemic therapy (chemotherapy/anti-angiogenic therapy/immune checkpoint inhibitors), nor have received 131I therapy, or if they have previously received 131I therapy, the lesions must still have iodine uptake capability as assessed by a physician; 5) Subjects with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 6) Eastern Cooperative Oncology Group (ECOG) performance status score of =1 and an expected survival of =3 months, with major organ functions meeting the criteria within 28 days prior to treatment; 7) Women of childbearing potential must agree to use contraceptive measures (such as intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after the study ends; they must have a negative serum pregnancy test within 28 days prior to study enrollment and must not be breastfeeding; men must agree to use contraceptive measures during the study and for 6 months after the study ends; 8) Assessed by the investigator as likely to benefit from the combination therapy of Donafenib and 131I.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; individuals planning to become pregnant within 6 months. 2) Participants with unhealed surgical incisions. 3) Presence of any signs or history of bleeding diathesis, or individuals who have experienced arterial/venous thrombotic events within the past 6 months. 4) Undifferentiated thyroid cancer, including medullary carcinoma originating from parafollicular cells. 5) Participants deemed ineligible for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease conotrol rate;Progression-free survival;Safety; | — |
Countries
China
Contacts
Public ContactLiu Wei
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed