Thyroid NeoplasmsNCT06367010
Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients
An observational study of Thyroid Neoplasms, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Iodine-125 brachytherapy combine with Anlotinib
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with radioiodine-refractory thyroid carcinoma can receive a radioactive 125I particle treatment combined with anilotinib.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Neoplasms
- Being tested
- Iodine-125 brachytherapy combine with Anlotinib
- Keywords
- Thyroid Neoplasms
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-125 brachytherapy combine with AnlotinibCombination product
Iodine-125 brachytherapy combine with Anlotinib
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assess within six months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2019
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijun Chen, Principal investigator, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367010
- Sponsor's protocol ID
- MR-36-24-010942
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20009446
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety Analysis of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients
- ClinicalTrials.gov ID
- NCT06367010
- Acronym / sponsor ID
- MR-36-24-010942
- Conditions
- Thyroid Neoplasms
- Keywords
- Thyroid Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with radioiodine-refractory thyroid carcinoma can receive a radioactive 125I particle treatment combined with anilotinib.
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (6 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine-125 brachytherapy combine with AnlotinibIodine-125 brachytherapy combine with Anlotinib | Combination product | – |
Primary outcome
The CT images were used to measure the change in the maximum diameter of the lesion in millimeters.
Time frame: Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
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].
Serological assessment
Time frame: Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
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).
Use the Numerical Rating Scale (NRS) to record patients' pain scores.
Time frame: Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.
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.
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Assess within six months after surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 20009446Watanabe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhijun Chen principal investigator
Jiangxi Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The CT images were used to measure the change in the maximum diameter of the lesion in millimeters. (time frame: Patients were evaluated preoperatively and at 2, 4, and 6 months postoperatively.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.