Locally Advanced Thyroid Gland CarcinomaPhase 2NCT06482086
Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
A Phase 2 study testing Anlotinib, Lenvatinib and Sorafenib in people with Locally Advanced Thyroid Gland Carcinoma, run by West China Hospital at 1 site in China.
Trial summary
The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Thyroid Gland Carcinoma
- What is being tested?
- Anlotinib, Lenvatinib and Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Dec 2025
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult participants who have either been initially diagnosed with locally advanced thyroid cancer or have experienced persistent or recurrent thyroid cancer, including cervical nodal recurrence. Types of pathology include:
- Papillary thyroid carcinoma (PTC)
- Follicular thyroid carcinoma (FTC)
- Medullary thyroid carcinoma (MTC)
- Poorly differentiated thyroid carcinoma (PDTC)
- Anaplastic thyroid carcinoma (ATC)
Show all 19Show fewer
- 2. Evidence of extrathyroidal extension and/or locally invasive disease and deemed at risk for R2 resection by treating team on clinical and/or fiberoptic examination and/or radiographic evaluation in the primary or recurrent setting. Evidence of "at risk for R2 resection" includes:
- Vocal cord paralysis by fiberoptic examination
- Extrathyroid and/or extranodal extension on CT or MRI, including tracheal and/or laryngeal cartilage invasion, esophageal involvement, and/or involvement of perithyroid muscles (e.g. strap, sternocleidomastoid, inferior constrictor muscles) or bone involvement
- Extension into the mediastinum with visceral and/or vascular involvement
- Involvement of the carotid artery or other major vessel by 180 degrees or more
- Other factors that make the participant to be "at risk for R2 resection" may be allowed, after discussion with the study's principal investigator.
- 3. There is at least one measurable lesion according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- 5. Normal organ and bone marrow function.
- 6. Adequate end-organ function (including bone marrow, coagulation, renal, liver and cardiac) 28 days prior to the study registration.
- 7. Ability to swallow pills.
- 8. Signed informed consent form.
- 9. Expected survival time of more than 2 months.
Who cannot join
- 1. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests.
- 2. Patients with incomplete clinical data.
- 3. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival.
- 4. Other active malignant disease requiring therapy.
- 5. Females who are pregnant or breastfeeding.
- 5. Patients without target lesions.
- 6. Patients deemed unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China hospital
Chengdu, Sichuan, 610041
Zhihui Li, Professor, 18980602027 ext. +86, rockoliver@vip.sina.com
About this study
Official title: Precision Medicine Applied to Locally Advanced Thyroid Cancer Using Tumor-derived Organoids and In-vitro Sensitivity Testing: a Phase 2a, Single-center, Open-label, and Non-comparative Study
The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients .
Read the detailed description
This research trial aims to determine the efficacy of organoid-guided targeted therapy for patients with locally advanced thyroid cancer. We will also investigate the variables affecting the effectiveness of targeted therapy for locally advanced thyroid cancer that is guided by organoids. Additionally, side effects related to the medication are also studied.
The following are the main questions that the trial seeks to address:
Can patients' tumor sizes be shrunk by taking medications that were found to be sensitive by organoid screening? Can patients' survival outcomes be improved by the medications that organoid screening found as sensitive? What aspects of the medications shown to be responsive by organoid screening are impacting their clinical efficacy? Is it possible for organoid-based drugs screening to guide treatment which lower surgical risk and make cancers that are now incurable into manageable ones? To ascertain the efficacy of the screened sensitive drugs in treating locally advanced thyroid cancer, researchers will measure the tumor size before and after taking the organoid-screened sensitive targeted drugs, assess the risk of radical resection, and document the survival outcomes of enrolled patients.
To further elucidate the parameters impacting the efficacy and prognosis, prognostic analysis based on clinical and pathological data, such as pathological type, gene mutation, age, tumor size, distant metastasis, and involvement of the trachea, esophagus, or major artery, will also be conducted.
The sample size for this study was determined based on the objective response rate (ORR) observed in our preliminary pilot study, which indicated an ORR of 22%. For papillary thyroid carcinoma (PTC), follicular thyroid carcinoma (FTC), and poorly differentiated thyroid carcinoma (PDTC), we aimed to detect a treatment effect with a minimum ORR of 12%, consistent with results from the previous multicenter, randomized, double-blind, placebo-controlled phase 3 trial (DECISION). For anaplastic thyroid carcinoma (ATC) and medullary thyroid carcinoma (MTC), we aimed to detect a treatment effect with a minimum ORR of 1%, considered the threshold for clinical efficacy.
To achieve a one-sided 95% confidence interval (α = 0.05), the Clopper-Pearson method was used to calculate the confidence interval for a proportion. This method ensured that the lower bound of the 95% confidence interval would exceed the minimum ORR (12% for PTC, FTC, and PDTC; 1% for ATC and MTC).
The calculation indicated that a total of 42 samples are needed for PTC, FTC, and PDTC, while 5 samples are required for both MTC and ATC.
Considering a 10% dropout rate and an 80% success rate for organoid drug sensitivity tests, a total of 59 samples are needed for PTC, FTC, and PDTC, while 7 samples are required for both MTC and ATC.
- Conditions
- Locally Advanced Thyroid Gland Carcinoma
- Being tested
- Anlotinib, Lenvatinib, Sorafenib, Donafenib, Everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks.
LenvatinibDrug
8/12 mg qd, po.
SorafenibDrug
0.4 g bid, po.
DonafenibDrug
0.3 g bid, po.
EverolimusDrug
10 mg qd, po.
ApatinibDrug
500 mg qd, po.
Dabrafenib + TrametinibDrug
Dabrafenib 150 mg bid, po+Trametinib 2 mg qd, po.
CabozantinibDrug
Cabozantinib 60mg qd, po.
VandetanibDrug
Vandetanib 300mg qd, po.
EntrectinibDrug
Entrectinib 600mg qd，po.
PralsetinibDrug
400mg qd, po.
LarotrectinibDrug
100mg qd，po
| Study group | Role | What they receive |
|---|---|---|
| Organoid-guided targeted therapeutic group | Experimental | Patients who take the recommended drugs regularly based on sensitivity analysis. Receives: Drug: Anlotinib; Drug: Lenvatinib; Drug: Sorafenib; Drug: Donafenib; Drug: Everolimus; Drug: Apatinib; Drug: Dabrafenib + Trametinib; Drug: Cabozantinib; Drug: Vandetanib; Drug: Entrectinib; Drug: Pralsetinib; Drug: Larotrectinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: Every 8 weeks until progression up to 3 years
Progress-free survival
PFS is defined as the time from the administration of the first dose to first disease progression or death.
Measured: Every 8 weeks until progression or death up to 3 years
Overall R0/R1 resection rate
Defined as the proportion of patients who undergo R0/R1 resection among all patients.
Measured: Up to 36 months.
Secondary outcomes (3)
Overall Survival
OS is defined as the time from the administration of the first dose to death.
Measured: Up to 36 months.
Change in Surgical complexity and morbidity score (SCMS)
The Thyroid Neck Group Morbidity Complexity Scoring and MGH/MEE-MSK-MD Anderson (MMM) Surgical Morbidity Complexity Score (SMCS) are incorporated, specifying on scale with 5 levels of complexity and morbidity of the surgery [mild (level 0), moderate (level 1), severe (level 2), very severe (level 3), and unresectable (level 4)]. The surgical morbidity/complexity scores will be collected at enrollment, prior to surgery, and based on intraoperative findings.
The change in SCMS will be reported as the median SCMS value. Determined by structures requiring resection, the score takes into account preoperatively radiographically defined structures judged to be requiring resection with surgical complexity of the given resection/potential for complications, and expected patient morbidity/change of function from the resection.
Measured: Up to 36 months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jun 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
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 Locally Advanced Thyroid Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhihui, West China Hospital
- Investigators
- Zhihui Li, Professor, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482086
- Sponsor's protocol ID
- 202314711
- Status last verified
- Dec 2024
- First submitted
- 15 Jun 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo Z, Liu J, Zhang X, Ma Y, Wang Y, Li P, Huang R, Li Z; MDT of Advanced Thyroid Cancer of West China Hospital. Precision treatment guided by patient-derived organoids-based drug testing for locally advanced thyroid cancer: a single arm, phase 2 study. Endocrine. 2025 Jul;89(1):186-196. doi: 10.1007/s12020-025-04240-9. Epub 2025 Apr 30.
PubMed 40304938
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Applied to Locally Advanced Thyroid Cancer Using Tumor-derived Organoids and In-vitro Sensitivity Testing: a Phase 2a, Single-center, Open-label, and Non-comparative Study
- ClinicalTrials.gov ID
- NCT06482086
- Acronym / sponsor ID
- 202314711
- Conditions
- Locally Advanced Thyroid Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Jul 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.
The current study aims to explore the potential advantages of anti-cancer therapy that is implemented based on drug sensitivity testing. This pertains to individuals with locally advanced thyroid cancer who have undergone conventional therapy in the past or unresectable patients .
Detailed description
This research trial aims to determine the efficacy of organoid-guided targeted therapy for patients with locally advanced thyroid cancer. We will also investigate the variables affecting the effectiveness of targeted therapy for locally advanced thyroid cancer that is guided by organoids. Additionally, side effects related to the medication are also studied.
The following are the main questions that the trial seeks to address:
Can patients' tumor sizes be shrunk by taking medications that were found to be sensitive by organoid screening? Can patients' survival outcomes be improved by the medications that organoid screening found as sensitive? What aspects of the medications shown to be responsive by organoid screening are impacting their clinical efficacy? Is it possible for organoid-based drugs screening to guide treatment which lower surgical risk and make cancers that are now incurable into manageable ones? To ascertain the efficacy of the screened sensitive drugs in treating locally advanced thyroid cancer, researchers will measure the tumor size before and after taking the organoid-screened sensitive targeted drugs, assess the risk of radical resection, and document the survival outcomes of enrolled patients.
To further elucidate the parameters impacting the efficacy and prognosis, prognostic analysis based on clinical and pathological data, such as pathological type, gene mutation, age, tumor size, distant metastasis, and involvement of the trachea, esophagus, or major artery, will also be conducted.
The sample size for this study was determined based on the objective response rate (ORR) observed in our preliminary pilot study, which indicated an ORR of 22%. For papillary thyroid carcinoma (PTC), follicular thyroid carcinoma (FTC), and poorly differentiated thyroid carcinoma (PDTC), we aimed to detect a treatment effect with a minimum ORR of 12%, consistent with results from the previous multicenter, randomized, double-blind, placebo-controlled phase 3 trial (DECISION). For anaplastic thyroid carcinoma (ATC) and medullary thyroid carcinoma (MTC), we aimed to detect a treatment effect with a minimum ORR of 1%, considered the threshold for clinical efficacy.
To achieve a one-sided 95% confidence interval (α = 0.05), the Clopper-Pearson method was used to calculate the confidence interval for a proportion. This method ensured that the lower bound of the 95% confidence interval would exceed the minimum ORR (12% for PTC, FTC, and PDTC; 1% for ATC and MTC).
The calculation indicated that a total of 42 samples are needed for PTC, FTC, and PDTC, while 5 samples are required for both MTC and ATC.
Considering a 10% dropout rate and an 80% success rate for organoid drug sensitivity tests, a total of 59 samples are needed for PTC, FTC, and PDTC, while 7 samples are required for both MTC and ATC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organoid-guided targeted therapeutic group | Experimental | Drug: Anlotinib, Drug: Lenvatinib, Drug: Sorafenib, Drug: Donafenib, Drug: Everolimus, Drug: Apatinib, Drug: Dabrafenib + Trametinib, Drug: Cabozantinib, Drug: Vandetanib, Drug: Entrectinib, Drug: Pralsetinib, Drug: LarotrectinibPatients who take the recommended drugs regularly based on sensitivity analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 1. Adult participants who have either been initially diagnosed with locally advanced thyroid cancer or have experienced persistent or recurrent thyroid cancer, including cervical nodal recurrence. Types of pathology include:
- 2. Evidence of extrathyroidal extension and/or locally invasive disease and deemed at risk for R2 resection by treating team on clinical and/or fiberoptic examination and/or radiographic evaluation in the primary or recurrent setting. Evidence of "at risk for R2 resection" includes:
- 3. There is at least one measurable lesion according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- 5. Normal organ and bone marrow function.
Key exclusion criteria (7 listed)
- 1. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests.
- 2. Patients with incomplete clinical data.
- 3. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival.
- 4. Other active malignant disease requiring therapy.
- 5. Females who are pregnant or breastfeeding.
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 |
|---|---|---|
| Anlotinib8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks. | Drug | Organoid-guided targeted therapeutic group |
| Lenvatinib8/12 mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| Sorafenib0.4 g bid, po. | Drug | Organoid-guided targeted therapeutic group |
| Donafenib0.3 g bid, po. | Drug | Organoid-guided targeted therapeutic group |
| Everolimus10 mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| Apatinib500 mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| Dabrafenib + TrametinibDabrafenib 150 mg bid, po+Trametinib 2 mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| CabozantinibCabozantinib 60mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| VandetanibVandetanib 300mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| EntrectinibEntrectinib 600mg qd，po. | Drug | Organoid-guided targeted therapeutic group |
| Pralsetinib400mg qd, po. | Drug | Organoid-guided targeted therapeutic group |
| Larotrectinib100mg qd，po | Drug | Organoid-guided targeted therapeutic group |
Primary outcome
Objective response rate
Time frame: Every 8 weeks until progression up to 3 years
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Progress-free survival
Time frame: Every 8 weeks until progression or death up to 3 years
PFS is defined as the time from the administration of the first dose to first disease progression or death.
Overall R0/R1 resection rate
Time frame: Up to 36 months.
Defined as the proportion of patients who undergo R0/R1 resection among all patients.
3 secondary outcomes
Overall Survival
Time frame: Up to 36 months.
Change in Surgical complexity and morbidity score (SCMS)
Time frame: Up to 36 months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Time frame: Up to 36 months
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 5 Dec 2024.
- Derived from this study: PubMed 40304938Guo Z, Liu J, Zhang X, Ma Y, Wang Y, Li P, Huang R, Li Z; MDT of Advanced Thyroid Cancer of West China Hospital. Precision treatment guided by patient-derived organoids-based drug testing for locally advanced thyroid cancer: a single arm, phase 2 study. Endocrine. 2025 Jul;89(1):186-196. doi: 10.1007/s12020-025-04240-9. Epub 2025 Apr 30.
- 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.
Zhihui Li, Professor study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib, Lenvatinib and Sorafenib in people with Locally Advanced Thyroid Gland Carcinoma, run by West China 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 19 inclusion and 7 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 5 Dec 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhihui Li, Professor (18980602027 ext. +86, rockoliver@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Every 8 weeks until progression up to 3 years). The study lists 3 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 NCT06482086, 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 5 Dec 2024.