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
West China Hospital
75 participants
Jun 1, 2021
INTERVENTIONAL
Conditions
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 .
Eligibility
Inclusion Criteria19
- \. 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)
- \. 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.
- \. There is at least one measurable lesion according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- \. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- \. Normal organ and bone marrow function.
- \. Adequate end-organ function (including bone marrow, coagulation, renal, liver and cardiac) 28 days prior to the study registration.
- \. Ability to swallow pills.
- \. Signed informed consent form.
- \. Expected survival time of more than 2 months.
Exclusion Criteria7
- \. Patients with contraindications specified in the drug instructions for the targeted drugs involved in the corresponding organoid drug sensitivity tests.
- \. Patients with incomplete clinical data.
- \. Patients with severe organ dysfunction, metabolic diseases, or other conditions significantly affecting survival.
- \. Other active malignant disease requiring therapy.
- \. Females who are pregnant or breastfeeding.
- \. Patients without target lesions.
- \. Patients deemed unsuitable for inclusion by the researchers.
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Interventions
8/10/12 mg qd, po. Stop the medication for one week after taking it for two weeks.
8/12 mg qd, po.
0.4 g bid, po.
0.3 g bid, po.
10 mg qd, po.
500 mg qd, po.
Dabrafenib 150 mg bid, po+Trametinib 2 mg qd, po.
Cabozantinib 60mg qd, po.
Vandetanib 300mg qd, po.
Entrectinib 600mg qd,po.
400mg qd, po.
100mg qd,po
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06482086