Clinical trial · Observational
Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients
Clinical Efficacy and Safety Analysis of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iodine-125 brachytherapy combine with Anlotinib | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- The CT images were used to measure the change in the maximum diameter of the lesion in millimeters.
- timeFrame
- Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
- description
- Lymph nodes were assessed based on their shortest diameter, while other target lesions were evaluated based on their longest diameter. Each measurable lesion underwent an average measurement derived from a minimum of three readings, with all measurements conducted by the same individual to minimize measurement discrepancies. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) were used to assess treatment response\[1\].
- measure
- Serological assessment
- timeFrame
- Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
- description
- Including serum Thyroglobulin (Tg) and serum Anti-thyroglobulin Antibody levels (TgAb) in thyrotropin-inhibited states, as well as tumor markers such as Carcinoembryonic Antigen (CEA).
- measure
- Use the Numerical Rating Scale (NRS) to record patients' pain scores.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * (i) Thyroid cancer confirmed through pathological examination; * (ii) Disease progression after conventional treatments, such as surgery, postoperative 131I, and external irradiation; * (iii) Multiple tumor foci, with at least one focus where the tumor's maximum diameter exceeds 3 cm. Exclusion Criteria: * (i) Patients who are positive for TgAb; * (ii) Patients with a TSH level of 0.1 mU/L or higher; * (iii) Patients with severe coagulation disorders; * (iv) Patients with severe cardiorespiratory impairment; * (v) Patients who are unable to cooperate with or tolerate particle implantation surgery; * (vi) Patients with an expected survival period of less than 3 months.
References
Publications (1)
- BACKGROUNDWatanabe H, Okada M, Kaji Y, Satouchi M, Sato Y, Yamabe Y, Onaya H, Endo M, Sone M, Arai Y. [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. Gan To Kagaku Ryoho. 2009 Dec;36(13):2495-501. Japanese. PMID 20009446