Advanced Thyroid Cancer Patients Who Received Target TherapyPhase 4NCT06195228
A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
A Phase 4 study testing dabrafenib plus trametinib with or without PD-1 antibody, entrectinib or larotrectinib with or without anti-PD-1 antibdoy and pralsetinib or selpercatinib with or without anti-PD-1 antibdoy in people with Advanced Thyroid Cancer Patients Who Received Target Therapy, run by Fudan University at 8 sites in China.
Trial summary
This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer. The retrospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 participated hospitals from January 2020 to December 2023 were retrieved. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Thyroid Cancer Patients Who Received Target Therapy
- What is being tested?
- dabrafenib plus trametinib with or without PD-1 antibody, entrectinib or larotrectinib with or without anti-PD-1 antibdoy and pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 8 sitesChina
- Study dates
- 1 Jan 2020to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients volunteered to participate in this study and signed informed consent;
- Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ;
- Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:
- Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC);
- Differentiated thyroid carcinoma not suitable for iodine therapy;
- Medullary thyroid carcinoma (MTC);
- poorly differentiated thyroid cancer (PDTC) or anaplastic thyroid cancer (ATC);
- Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.
Who cannot join
- Patients who are participating in clinical trials of other drugs;
- There is evidence that the patients are pregnant or lactating;
- Other situations that are not suitable for inclusion in this study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking union medical college hospital
Beijing, 100000
Yansong Lin, M.D., (010)69156699, linyansong1968@163.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Yu Wu, M.D, 13705003480, headandneck2018@126.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Meiyu Fang, M.D, 13750851650, fangmy@zjcc.org.cn
Liang Guo
- Recruiting
Caixia Liu
Hohhot, Inner Mongolia, 010000
Caixia Liu, M.D, 18847189559, lcxzhg1974@163.com
M.D
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dongmei Ji, M.D, +8602164175590 ext. 73546, jidongmei2000@126.com
- Recruiting
Shanxi Cancer Hospital
Shanxi, Taiyuan, 030000
Linzi Jia, M.D, 15035162908, jialz2008@163.com
Jia Linzi, M.D
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Wei Cao, M.D, 13995658573, caowei@hust.edu.cn
Wei Cao
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Jianwu Qin, M.D, 13598802366, qinjianwu62@163.com
About this study
This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer.
The retrospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 participated hospitals from January 2020 to December 2023 were retrieved. The number of previous treatment lines was not limited. Patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. Demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected.
The prospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 Chinese hospitals from January 2024 to April 2027 were enrolled.
Read the detailed description
see:Arms and Interventions
- Being tested
- dabrafenib plus trametinib with or without PD-1 antibody, entrectinib or larotrectinib with or without anti-PD-1 antibdoy, pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, anlotinib or anlotinib plus anti-PD-1 antibody, lenvatinib plus anti-PD-1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenib plus trametinib with or without PD-1 antibodyDrug
advanced thyroid cancer patients who harbor BRAF V600E mutation
entrectinib or larotrectinib with or without anti-PD-1 antibdoyDrug
advanced thyroid cancer patients who harbor NTRK mutation
pralsetinib or selpercatinib with or without anti-PD-1 antibdoyDrug
advanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation.
anlotinib or anlotinib plus anti-PD-1 antibodyDrug
For patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown
lenvatinib plus anti-PD-1 antibodyDrug
Advanced thyroid cancer patients who don't harbor the above gene mutation or could not afford the cost of precision treatment even with the above gene mutation
Other Targets: precise treatment based on the targetDrug
Advanced thyroid cancer patients who had other treatment targets not included above
| Study group | Role | What they receive |
|---|---|---|
| Radioiodine-refractory differentiated thyroid cancer | Experimental | advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment Receives: Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: anlotinib or anlotinib plus anti-PD-1 antibody; Drug: lenvatinib plus anti-PD-1 antibody; Drug: Other Targets: precise treatment based on the target |
| Differentiated thyroid carcinoma not suitable for radioiodine therapy | Experimental | advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy Receives: Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: anlotinib or anlotinib plus anti-PD-1 antibody; Drug: lenvatinib plus anti-PD-1 antibody; Drug: Other Targets: precise treatment based on the target |
| Medullary thyroid cancer | Experimental | patients with advanced or metastatic medullary thyroid cancer Receives: Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: anlotinib or anlotinib plus anti-PD-1 antibody; Drug: lenvatinib plus anti-PD-1 antibody; Drug: Other Targets: precise treatment based on the target |
| High-grade or poorly differentiated thyroid cancer | Experimental | patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer Receives: Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: anlotinib or anlotinib plus anti-PD-1 antibody; Drug: lenvatinib plus anti-PD-1 antibody; Drug: Other Targets: precise treatment based on the target |
| Anaplastic thyroid cancer | Experimental | patients with anaplastic thyroid cancer Receives: Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: anlotinib or anlotinib plus anti-PD-1 antibody; Drug: lenvatinib plus anti-PD-1 antibody; Drug: Other Targets: precise treatment based on the target |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Complete remission rate+ partial remission rate
Measured: up to approximately 3 years
Secondary outcomes (5)
Duration of Response(DOR)
Time from the date of first partial remission or complete remission to the date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: up to approximately 3 years
Disease Control Rate(DCR)
Complete remission rate+ partial remission rate+stable disease rate
Measured: up to approximately 3 years
Time to response(TTR)
Time from the initiation of the treatment to the first remission
Measured: up to approximately 3 years
Progression Free Survival(PFS)
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: up to approximately 3 years
Overall survival(OS)
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Thyroid Cancer Patients Who Received Target TherapyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanxi Province Cancer Hospital, Henan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang Cancer Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Ruijin Hospital, Fujian Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shanghai 6th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Changhai Hospital, Tianjin Medical University Cancer Institute and Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hunan Provincial People's Hospital, Dalian Friendship Hospital Affiliated to Dalian Medical University, The Third Affiliated Hospital of Soochow University, Sun Yat-sen University, Liaoning Cancer Hospital & Institute, Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Ji Dongmei, Fudan University
- Investigators
- Dongmei Ji, M.D, Principal investigator, Fudan UniversityYu Wang, M.D, Principal investigator, Fudan UniversityQinghai Ji, M.D, Principal investigator, Fudan UniversityYansong Lin, M.D, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195228
- Sponsor's protocol ID
- FUSCC-TC-RWS01
- Status last verified
- Aug 2025
- First submitted
- 23 Dec 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06195228
- Acronym / sponsor ID
- FUSCC-TC-RWS01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanxi Province Cancer Hospital, Henan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang Cancer Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Ruijin Hospital, Fujian Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shanghai 6th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Changhai Hospital, Tianjin Medical University Cancer Institute and Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hunan Provincial People's Hospital, Dalian Friendship Hospital Affiliated to Dalian Medical University, The Third Affiliated Hospital of Soochow University, Sun Yat-sen University, Liaoning Cancer Hospital & Institute, Sir Run Run Shaw Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 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.
This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer.
The retrospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 participated hospitals from January 2020 to December 2023 were retrieved. The number of previous treatment lines was not limited. Patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. Demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected.
The prospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 Chinese hospitals from January 2024 to April 2027 were enrolled.
Detailed description
see:Arms and Interventions
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Radioiodine-refractory differentiated thyroid cancer | Experimental | Drug: dabrafenib plus trametinib with or without PD-1 antibody, Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy, Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, Drug: anlotinib or anlotinib plus anti-PD-1 antibody, Drug: lenvatinib plus anti-PD-1 antibody, Drug: Other Targets: precise treatment based on the targetadvanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment |
| Differentiated thyroid carcinoma not suitable for radioiodine therapy | Experimental | Drug: dabrafenib plus trametinib with or without PD-1 antibody, Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy, Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, Drug: anlotinib or anlotinib plus anti-PD-1 antibody, Drug: lenvatinib plus anti-PD-1 antibody, Drug: Other Targets: precise treatment based on the targetadvanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy |
| Medullary thyroid cancer | Experimental | Drug: dabrafenib plus trametinib with or without PD-1 antibody, Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy, Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, Drug: anlotinib or anlotinib plus anti-PD-1 antibody, Drug: lenvatinib plus anti-PD-1 antibody, Drug: Other Targets: precise treatment based on the targetpatients with advanced or metastatic medullary thyroid cancer |
| High-grade or poorly differentiated thyroid cancer | Experimental | Drug: dabrafenib plus trametinib with or without PD-1 antibody, Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy, Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, Drug: anlotinib or anlotinib plus anti-PD-1 antibody, Drug: lenvatinib plus anti-PD-1 antibody, Drug: Other Targets: precise treatment based on the targetpatients with advanced or metastatic High-grade or poorly differentiated thyroid cancer |
| Anaplastic thyroid cancer | Experimental | Drug: dabrafenib plus trametinib with or without PD-1 antibody, Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy, Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, Drug: anlotinib or anlotinib plus anti-PD-1 antibody, Drug: lenvatinib plus anti-PD-1 antibody, Drug: Other Targets: precise treatment based on the targetpatients with anaplastic thyroid cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients volunteered to participate in this study and signed informed consent;
- Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ;
- Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:
- Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.
Key exclusion criteria (3 listed)
- Patients who are participating in clinical trials of other drugs;
- There is evidence that the patients are pregnant or lactating;
- Other situations that are not suitable for inclusion in this study.
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 |
|---|---|---|
| dabrafenib plus trametinib with or without PD-1 antibodyadvanced thyroid cancer patients who harbor BRAF V600E mutation | Drug | Anaplastic thyroid cancer, Differentiated thyroid carcinoma not suitable for radioiodine therapy, High-grade or poorly differentiated thyroid cancer, Medullary thyroid cancer, Radioiodine-refractory differentiated thyroid cancer |
| entrectinib or larotrectinib with or without anti-PD-1 antibdoyadvanced thyroid cancer patients who harbor NTRK mutation | Drug | Anaplastic thyroid cancer, Differentiated thyroid carcinoma not suitable for radioiodine therapy, High-grade or poorly differentiated thyroid cancer, Medullary thyroid cancer, Radioiodine-refractory differentiated thyroid cancer |
| pralsetinib or selpercatinib with or without anti-PD-1 antibdoyadvanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation. | Drug | Anaplastic thyroid cancer, Differentiated thyroid carcinoma not suitable for radioiodine therapy, High-grade or poorly differentiated thyroid cancer, Medullary thyroid cancer, Radioiodine-refractory differentiated thyroid cancer |
| anlotinib or anlotinib plus anti-PD-1 antibodyFor patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown | Drug | Anaplastic thyroid cancer, Differentiated thyroid carcinoma not suitable for radioiodine therapy, High-grade or poorly differentiated thyroid cancer, Medullary thyroid cancer, Radioiodine-refractory differentiated thyroid cancer |
| lenvatinib plus anti-PD-1 antibodyAdvanced thyroid cancer patients who don't harbor the above gene mutation or could not afford the cost of precision treatment even with the above gene mutation | Drug | Anaplastic thyroid cancer, Differentiated thyroid carcinoma not suitable for radioiodine therapy, High-grade or poorly differentiated thyroid cancer, Medullary thyroid cancer, Radioiodine-refractory differentiated thyroid cancer |
| Other Targets: precise treatment based on the targetAdvanced thyroid cancer patients who had other treatment targets not included above | Drug | Anaplastic thyroid cancer, Differentiated thyroid carcinoma not suitable for radioiodine therapy, High-grade or poorly differentiated thyroid cancer, Medullary thyroid cancer, Radioiodine-refractory differentiated thyroid cancer |
Primary outcome
Objective Response Rate(ORR)
Time frame: up to approximately 3 years
Complete remission rate+ partial remission rate
5 secondary outcomes
Duration of Response(DOR)
Time frame: up to approximately 3 years
Disease Control Rate(DCR)
Time frame: up to approximately 3 years
Time to response(TTR)
Time frame: up to approximately 3 years
Progression Free Survival(PFS)
Time frame: up to approximately 3 years
Overall survival(OS)
Time frame: up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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.
Dongmei Ji, M.D principal investigator
Fudan University
Yu Wang, M.D principal investigator
Fudan University
Qinghai Ji, M.D principal investigator
Fudan University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dabrafenib plus trametinib with or without PD-1 antibody, entrectinib or larotrectinib with or without anti-PD-1 antibdoy and pralsetinib or selpercatinib with or without anti-PD-1 antibdoy in people with Advanced Thyroid Cancer Patients Who Received Target Therapy, run by Fudan University at 8 sites 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Ji, M.D (021-64175590 ext. 83650, jidongmei2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.