Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
NCT ID: NCT06482086
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2021-06-01
2025-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Organoid-guided targeted therapeutic group
Patients who take the recommended drugs regularly based on sensitivity analysis.
Anlotinib
8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks.
Lenvatinib
8/12 mg qd, po.
Sorafenib
0.4 g bid, po.
Donafenib
0.3 g bid, po.
Everolimus
10 mg qd, po.
Apatinib
500 mg qd, po.
Dabrafenib + Trametinib
Dabrafenib 150 mg bid, po+Trametinib 2 mg qd, po.
Cabozantinib
Cabozantinib 60mg qd, po.
Vandetanib
Vandetanib 300mg qd, po.
Entrectinib
Entrectinib 600mg qd，po.
Pralsetinib
400mg qd, po.
Larotrectinib
100mg qd，po
Interventions
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Anlotinib
8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks.
Lenvatinib
8/12 mg qd, po.
Sorafenib
0.4 g bid, po.
Donafenib
0.3 g bid, po.
Everolimus
10 mg qd, po.
Apatinib
500 mg qd, po.
Dabrafenib + Trametinib
Dabrafenib 150 mg bid, po+Trametinib 2 mg qd, po.
Cabozantinib
Cabozantinib 60mg qd, po.
Vandetanib
Vandetanib 300mg qd, po.
Entrectinib
Entrectinib 600mg qd，po.
Pralsetinib
400mg qd, po.
Larotrectinib
100mg qd，po
Eligibility Criteria
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Inclusion Criteria
1. Papillary thyroid carcinoma (PTC)
2. Follicular thyroid carcinoma (FTC)
3. Medullary thyroid carcinoma (MTC)
4. Poorly differentiated thyroid carcinoma (PDTC)
5. Anaplastic thyroid carcinoma (ATC)
* 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:
1. Vocal cord paralysis by fiberoptic examination
2. 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
3. Extension into the mediastinum with visceral and/or vascular involvement
4. Involvement of the carotid artery or other major vessel by 180 degrees or more
5. 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Li Zhihui
Dean of the Thyroid Surgery Department
Principal Investigators
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Zhihui Li, Professor
Role: STUDY_DIRECTOR
West China Hospital
Locations
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West China hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Zhihui Li, Professor
Role: primary
References
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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.
Other Identifiers
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202314711
Identifier Type: -
Identifier Source: org_study_id