Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients

Thyroid Neoplasms Clinical Trial

Official title:

Clinical Efficacy and Safety Analysis of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06367010
• Other study ID #: MR-36-24-010942
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Jiangxi Provincial Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Combination Product:
• Iodine-125 brachytherapy combine with Anlotinib
Iodine-125 brachytherapy combine with Anlotinib

Locations

Country	Name	City	State
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.