Clinical trial · Interventional
Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
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
NCT06482086CI-TRIAL-00083341recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Thyroid Gland Carcinoma | Thyroid Gland Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Apatinib | Drug | — | UNRESOLVED |
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Dabrafenib + Trametinib | Drug | Dabrafenib/Trametinib Regimen | ALIAS |
| Donafenib | Drug | — | UNRESOLVED |
| Entrectinib | Drug | Entrectinib | ALIAS |
| Everolimus | Drug | Everolimus | ALIAS |
| Larotrectinib | Drug | Larotrectinib | ALIAS |
| Lenvatinib |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Organoid-guided targeted therapeutic group
- description
- Patients who take the recommended drugs regularly based on sensitivity analysis.
- interventionNames
- 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
Primary outcomes (3)
- measure
- Objective response rate
- timeFrame
- Every 8 weeks until progression up to 3 years
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 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: * 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.
References
Publications (1)
- DERIVEDGuo 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. PMID 40304938