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

NCT06367010 | Completed

• 1 other identifier: MR-36-24-010942
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Neoplasms

Keywords

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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.

Interventions

Iodine-125 brachytherapy combine with Anlotinib COMBINATION_PRODUCT

Iodine-125 brachytherapy combine with Anlotinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Related 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.

  PMID: 20009446 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Blood sample

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Zhijun Chen

  Jiangxi Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: January 1, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)