Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting now · Phase 2

Conditions studied: Locally Advanced Thyroid Gland Carcinoma

In brief

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 .

Key facts

Study ID

NCT06482086

Run by

West China Hospital

People needed

75

Starts

2021-06-01

Expected to finish

2025-12-01

Last updated by the study team

2024-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• West China hospital — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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