Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367010
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients
Sponsor:
Jiangxi Provincial Cancer Hospital
Organization:
Jiangxi Provincial Cancer Hospital
Study Overview
Official Title:
Clinical Efficacy and Safety Analysis of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 50The data were analyzed using IBM SPSS 270
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 11 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 50The data were analyzed using IBM SPSS 270
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None