Using organoid testing to find effective treatments for 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
This study tests if using lab-grown mini tumors can help find the best treatments for people with advanced thyroid cancer to improve their outcomes and lower surgery risks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06482086 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of organoid-based drug screening to guide targeted therapy for patients with locally advanced thyroid cancer. Participants will receive medications identified as sensitive through organoid testing, and the study will measure tumor size changes and survival outcomes. Additionally, the trial will analyze various factors that may influence the effectiveness of these treatments, including tumor characteristics and patient demographics. The goal is to determine if this personalized approach can improve treatment outcomes and reduce surgical risks for patients with advanced disease.
Who should consider this trial
Good fit: Ideal candidates include adults with locally advanced thyroid cancer who have not responded to conventional therapies or have unresectable tumors.
Not a fit: Patients with early-stage thyroid cancer or those who have not been diagnosed with locally advanced disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with locally advanced thyroid cancer.
How similar studies have performed: While organoid-based drug screening is a novel approach, similar studies in other cancer types have shown promising results in personalizing treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chengdu, Sichuan
- West China hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Zhihui Li, Professor
- Email: rockoliver@vip.sina.com
- Phone: 18980602027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.