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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Neoplasms
• Intervention / Treatment: Combination product: Iodine-125 brachytherapy combine with Anlotinib

Detailed Description

A retrospective analysis was conducted on RRTC patients who underwent radioactive 125I seed implantation combined with anlotinib from 2019 to 2024 at Jiangxi Cancer Hospital, including 2 cases of papillary thyroid carcinoma (PTC), 4 cases of follicular thyroid carcinoma (FTC), and 2 cases of medullary thyroid carcinoma (MTC).

Prior to the treatment, patients were informed about their condition, the expected efficacy, and the potential side effects and toxic effects of 125I seed implantation therapy combined with anlotinib. All patients accepted the treatment plan and signed an informed consent form. The preoperative evaluation process includes assessments of coagulation function, liver and kidney function, cardiopulmonary function, and local CT scans.

A collaborative effort between physicians and physicists was undertaken to establish a treatment regimen with a prescription dose ranging from 80 to 120 Gy. The CT-guided 125I seed implantation procedure was conducted according to the prescribed treatment regimen. On the day of completion of the 125I seed implantation procedure, all patients began treatment with anlotinib. Patients undergo 14 consecutive days of treatment followed by 7 days off, constituting one cycle. This cycle is repeated until progressive disease (PD) occurs or the patient shows intolerance to the treatment.

Subsequent evaluations were scheduled post-surgery, focusing on lesion dimensions, serum Tg levels, pain levels, and adverse reactions. Lesion size was determined using CT imaging. 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) [1] were used to assess treatment response. Use the Visual Analogue Scale to record patients' pain scores. Adverse reactions, including infection, bleeding, pneumothorax, bone marrow suppression, and seed displacement, were recorded. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.The data were analyzed using IBM SPSS 27.0.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with radioiodine-refractory thyroid carcinoma can receive a radioactive 125I particle treatment combined with anilotinib.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The CT images were used to measure the change in the maximum diameter of the lesion in millimeters.	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].	Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
Serological assessment	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).	Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
Use the Numerical Rating Scale (NRS) to record patients' pain scores.	The scale ranges from 0 to 10 points, with pain increasing incrementally. 0 indicates no pain, 1-3 indicate mild pain that is still tolerable and does not interfere with sleep or normal life, 4-6 indicate moderate pain that interferes with sleep and requires analgesic medication to alleviate it, and 7-10 show intense and intolerable pain that seriously interferes with sleep and diet and requires strong analgesic drugs.	Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Adverse reactions, such as pain, pneumothorax, hemorrhage, myelosuppression, infection, radiation inflammation, necrosis, hand-foot syndrome, hypertension, proteinuria, and diarrhea, were observed and recorded. The severity of the adverse reactions was graded according to the CTCAE v5.0, with grades ranging from 1 to 5, where grade 1 represents the mildest and grade 5 the most severe.	Assess within six months after surgery.

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital
• Investigators: Principal Investigator: Zhijun Chen, Jiangxi Provincial Cancer Hospital

Publications and helpful links

General Publications

• Watanabe 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 14, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Thyroid Neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: MR-36-24-010942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No