Tests drug choice using tumor organoids in locally advanced thyroid cancer
Tests whether drug choice guided by tumor sensitivity testing helps adults with advanced thyroid cancer.
Plain-language title generated from the registry record
Registry title: Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 2
Where in China
- West China HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- West China Hospital
- Trial code
- NCT06482086
- Record updated
- 5 December 2024
- Original description
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 full original descriptionShow less
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 .
Inclusion: 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); 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.
Exclusion: 1. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests; 3. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival; 4. Other active malignant disease requiring therapy; 2. Patients with incomplete clinical data; 5. Females who are pregnant or breastfeeding; 5. Patients without target lesions; 6. Patients deemed unsuitable for inclusion by the researchers.